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Category: Regulatory

Understanding the ISO 18562:2024 Standards Update for Medical Devices

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The updated ISO 18562 standards, released in March 2024, now cover medical respiratory PPE like surgical masks and introduce new terms that could change testing requirements for medical devices. They emphasize the importance of considering a device’s aging and life cycle, as well as providing detailed breathing volumes for expanded patient populations. These changes aim to enhance safety evaluations for devices throughout their use, presenting manufacturers with new challenges.

Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

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The FDA’s updated guidance on race and ethnicity data collection in clinical trials calls for using OMB-standardized categories to ensure accurate demographic representation. Sponsors must create a Diversity Action Plan, with mandatory implementation for new studies within 180 days after final guidance. Participants will self-report race and ethnicity, with the option to identify as multiracial and confirm their information against medical records.

Medical Device Software: Considerations for Device and Risk Characterization

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On February 2, 2024, the IMDRF released a draft guidance for public comment on Software as a Medical Device (SaMD). This document aims to unify global regulations by detailing device characterization and risk assessment for medical software. It seeks to create a shared understanding that can navigate the varied regulatory landscapes, promoting safer digital health solutions. Public feedback is encouraged to refine these critical guidelines.

Revolutionizing Healthcare: The Rise of Medical Device Software and EU Regulatory Compliance

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In the rapidly evolving field of healthcare technology, NAMSA provides expert guidance on navigating the complex regulatory landscape for Medical Device Software (MDSW) in Europe. The blog discusses the importance of clinical and performance evaluations according to EU regulations, highlighting the challenges manufacturers face in demonstrating safety and effectiveness. It emphasizes the need for thorough data analysis and risk assessment, particularly in areas like software safety, risk classification, and the lifespan of MDSW. NAMSA’s specialized medical writing teams offer their extensive expertise to assist MDSW manufacturers in achieving compliance and fostering innovation within the digital health space.

FDA Town Hall Series on Ethylene Oxide Sterilization and Alternative Sterilization Modalities

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Explore FDA efforts to reduce EO use in medical device sterilization, the rise of VHP, and how NAMSA can assist with sterilization validation.

MDCG 2024-2: Procedures for the Updates of the European Medical Device Nomenclature

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Learn about EMDN updates in the new MDCG 2024-2 guidance and its impact on medical device manufacturers.

MDR Vigilance: New MDCG Guidance Published

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This blog covers the EU Commission’s newly published MDCG Guidance documents relating to medical device and in vitro diagnostic medical device vigilance.

Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

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This blog covers the FDA issued guidance on using digital health technologies for remote data acquisition in clinical investigations, allowing for remote data collection from trial participants.

European Commission Updates Chemical Classification and Labeling

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This blog covers the latest updates to the European Commission’s harmonized classification and labeling of chemicals, including significant changes to the CLP Regulation that could impact medical devices.

Navigating the Transition: Understanding the EU’s Proposed Amendments to IVDR

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This blog delves into the recent amendments to the IVDR and how it will affect both transition timelines and requirements.

ISO 10993-17:2023 Update: Key Changes and FDA Recognition

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This blog delves into the changes to ISO 10993-17, released in 2023. Included are several major additions to the toxicological risk assessment process.

MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

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This blog delves into the changes in the MDCG 2021-6 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.

MDCG 2022-11 Rev 1: Urgency for MDR and IVDR Compliance

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This blog delves into the changes in the MDCG 2022-11 Revision 1 and NAMSA Experts’ take on what the changes mean for manufacturers.

Five Reasons Not to Delay Your MDR Certification

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This blog delves into the approaching deadlines and reasoning for moving forward with MDR certifications now.

Why IVD Developers Must Embrace the IVDR Transition Now

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This blog delves into the crucial transition from the In Vitro Diagnostic Device Directive (IVDD) to the IVDR, highlighting the pressing need for developers to take immediate action.

What is an EDC System and How Does it Support Clinical Trials?

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On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

MDCG 2023-4: Medical Device Software (MDSW) – Hardware Combinations

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In this blog, we assess if MDCG 2023-4, published in October 2023, lessens the regulatory burden and clarifies the route to conformity for medical device Apps.

FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles”

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On October 24, 2023, the FDA, Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly publishing the “Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles.” This new publication is intended to lay the foundation for PCCPs for Machine Learning-Enabled Medical Devices and encourage international harmonization.

ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices

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The new ANSI/AAMI ST98 standard, published in 2022, is a long awaited clarification of the strategy for cleaning validations for reusable medical devices. The standard serves as a key regulatory guideline to support device manufacturers in their regulatory submissions.

FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

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At the end of July 2023, the United States Food and Drug Administration (FDA) issued a release indicating that they have recognized the following sterilization standard and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes.

The Swiss MedTech Landscape

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Since May 2021, Switzerland’s MRA with the EU is no longer applicable, posing potential challenges to the availability of medical products in the long term. To address this situation and avoid potential shortages of medical products, Switzerland has initiated the process of establishing mutual recognition agreements with other regions.

FDA Publishes Updated Guidance for Breakthrough Devices Program

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On September 15, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Breakthrough Devices Program. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018.

FDA Announces Three New Guidances Dedicated to 510(k) Submissions

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On September 6, 2023, the U.S. Food and Drug Administration (FDA) released a statement about the issuance of the three new guidances as part of their effort to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices.

FDA Revised its Final Guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program”

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On June 2, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

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On August 2, 2023, the U.S. Food and Drug Administration (FDA) published a Federal Register notice that modifications were being made to the Recognized Consensus Standards for Medical Devices database.

UK Extends Transition Period for Medical Device and IVD Products in New Legislation

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The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.

Reflecting on the Second Anniversary of the EU Medical Device Regulation

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The Medical Device Regulation (MDR) marked a significant overhaul of the regulatory process for devices in the EU, replacing the Medical Device Directive (MDD) with patient safety a priority. As is often the case with the introduction of new regulatory requirements, manufacturers have faced numerous challenges.

Just Released: Updated Transitional Arrangements for UKCA Process

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On 28 April 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) published a communication updating previous information on the extension period for the mandatory implementation of the United Kingdom Conformity Assessment (UKCA) process for medical devices. This update is resultant from the recent amendment by the EU Commission (EU 2023/607) to extend the transition period for MDR 2017/745.

AI Guidance for Medical Devices | NAMSA

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On March 30, 2023, the U.S. FDA issued draft guidance outlining the use of Predetermined Change Control Plans (PCCPs) for AI/ML software.

UK MHRA Advisory Group Publishes Proposals

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On 7 March, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published the minutes of their Advisory Group, recommending ten (10) specific proposals to International Recognition, Routes for Innovation and System Capacity.

European Parliament to Amend MDR/IVDR Transitional Provisions

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On 16 February 2023, the European Parliament voted to adopt an amendment that affects Article 120 and Article 110 of Regulations (EU) 2017/745 and (EU) 2017/746, respectively. The amendment only extends the transitional period for legacy medical devices, but also removes the sell-off period for both medical and in vitro diagnostic (IVD) devices.

U.S. FDA Emergency Use Authorization: CRO Lessons Learned for the MedTech Industry

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During the COVID-19 Pandemic, the FDA CDRH put the hardest, longest and most intensive work into reviewing EUA applications for COVID-19 diagnostic tests. The result was a shift in how the FDA, MedTech manufacturers and CROs conduct work, which is still in place today. 

Health Canada and FDA eSTAR Pilot

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On January 10, 2023, the U.S. Food and Drug Administration (FDA) and Health Canada announced a new joint pilot program. This program will conduct tests on the use of FDA’s eSTAR to make a single medical device submission to both FDA and Health Canada.

MDR Update: EPSCO Proposes Transition Improvements and EU Commission Issues MDCG 2022-18

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At the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) meeting on 9 December 2022, EU Member States unanimously agreed that actions should be taken to ensure that the supply of medical devices is maintained during the Medical Device Regulation (MDR) transition period. Specific issues regarding Notified Body capacity and ongoing expiration of the EU’s Medical Device Directive (MDD) certificates during transition were the main concerns.

EU Commission Publishes MDR Implementing Regulation for Devices without Medical Purpose (Annex XVI)

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In an important step forward for EU manufacturers of devices without a medical purpose, the final version of the ‘Implementing Regulation’ containing the common specifications related to the Medical Device Regulation (MDR) have been adopted.

Auditing a QMS According to ISO 13485

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Medical device manufacturers must first ensure that their QMS conforms to the specified requirements and is effectively implemented and maintained. On the path towards ISO 13485 certification, manufacturers should undergo an internal audit and then an external certification audit. This article supports manufacturers in understanding the auditing process toward ISO 13485 certification.

FDA Releases Long-Awaited Final Guidance for Clinical Decision Support Software

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On the heels of the September 26 release of the FDA’s, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings,” the regulatory authority has released the long-awaited final guidance for “Clinical Decision Support Software” (September 28, 2022). This final guidance replaces the 2017 and 2019 draft guidance documents.

Digital Health Software Pre-Certification Update: Final FDA Report Revealed

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On September 26, 2022, the FDA a final report entitled, “Digital Health Software Precertification (Pre-Cert) Pilot Program: Tailored Total Product Lifecycle Approaches and Key Findings.” The Pre-Cert Program is intended to fast-track digital health products by reducing regulatory hurdles for developers of Software as a Medical Device (SaMD).

Monkeypox: Not all EUAs Are Created Equal

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The FDA declared a public health emergency for monkeypox on August 4, 2022 and authorized EUAs for diagnostic tests as of September 7, 2022. For this latest policy, the FDA is inviting experienced test developers with high manufacturing capacity to notify the FDA of their intent to submit an EUA request by October 13, 2022.

First Manual on Borderline and Classification under MDR Published by the European Commission

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On the 7 September 2022, the European Commission announced publication of the latest manual on borderline and classification in the community regulatory framework for medical devices and In Vitro Diagnostic medical devices (Borderline Manual). This is the first version of the manual published under the requirements of the EU MDR.

MDCG 2022-14: Transition to the MDR and IVDR – Notified Body Capacity and Availability of Medical Devices and IVDs

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On 14 June 2022, the European Health Ministers met and echoed concerns surrounding the preparedness of medical device and IVD manufacturers for Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) conformity. If left unaddressed, the lack of preparedness may lead to the disruption of the supply of devices needed for health systems and patients, and could also jeopardize the access of innovative medical devices to the European market.

MDCG 2022-10: Interfaces between the Clinical Trial Regulation and IVDR

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Assays used in clinical trials may range from CE-marked IVDs to trial- or medicinal product-specific assays that are not always meant to be developed as IVDs. In order to assure that conformity is maintained on both the drug and device sides, MDCG—with the Clinical Trials Expert Group (CTG)—have published a Q&A document to clarify requirements for these assays.

MDCG 2022-3: Verification of Manufactured Class D IVDs in accordance to the IVDR—One Size Fits All?

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One of the most compelling requirements in the IVDR EU regulation deals with two important aspects of conformity assessments of Class D IVD medical products: namely, the batch verification process and the involvement of EU reference laboratories that conduct these processes. In February 2022, a new guidance document was released by the Medical Devices Coordination Group (MDCG) that allows a more precise interpretation of these requirements: MDCG—Verification of Manufactured Class D IVDs by Notified Bodies.

The New UK MHRA Medical Device Regulations: Impact to IVD Manufacturers

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Within this blog post, we will highlight IVD-specific issues, including areas of difference between the new MHRA regulations in contrast to EU regulations—and more specifically, the IVDR/MDR. We will also discuss new areas related to innovation/routes to the UK market and processes put in place to ensure that IVD devices are available on the UK market after the implementation date of the UKCA (1 July 2023). 

Navigating the 510(k) EO Sterility Change Master File Program

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In May 2022, the FDA announced the 510(k) Sterility Change Master File Pilot Program in the Federal Register. Under the Pilot Program, the sterilization provider compiles and submits a Master File to FDA and, in the event the MAF is accepted and the 510(k) holder is granted a right of reference to the MAF, submission of a new 510(k) for the sterilization change may not be required.

New UK MHRA Medical Devices Regulations Published

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On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the consultation process regarding the new Medical Device Regulations for the UK. The final proposals contain comprehensive coverage of the various requirements to be included in the new UK Medical Device Regulations guidance. These new regulations are primarily based on EU Medical Device Regulation (MDR) 2017/745 requirements, but with significant differences in some key areas and new requirements surrounding new and innovative medical devices.

Utilization of Least Burdensome Principles during FDA Reviews Benefits Industry

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The principles provided in the FDA’s Least Burdensome Provisions Guidance offer useful tools to assess evidence requirements and information on how to effectively navigate the regulatory review process in the United States.

New MDCG 2022-5 Guidance on Borderline between Devices and Drugs under MDR

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In late April 2022, the long-awaited Medical Device Coordination Group (MDCG) guidance on borderline devices under the Medical Device Regulation (MDR) was published. In this newly-released guidance, the MDCG essentially replaces the borderline guidance in MEDDEV 2.1/3 Rev3, originally written for the EU Medical Device Directive (MDD).

FDA Announces Optional Pathway for Clearance of Surgical Sutures

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The FDA issued a final guidance on April 11, 2022, establishing the performance criteria for surgical sutures, allowing for clearance of devices through the Safety and Performance Based Pathway.

FDA Reissues Draft Guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

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On April 7, 2022, the U.S. Food and Drug Administration (FDA) announced the release of draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”

New MDCG 2022-4 Guidance Released

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ew Medical Device Coordination Group (MDCG) guidance document, MDCG 2022-4: “Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD,” was published on the 16 February 2022. It provides information for both manufacturers and Notified Bodies (NBs) concerning the transition requirements for legacy medical devices.

Industry Update: U.S. FDA Quality Management System Regulation

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On March 2, 2022, the U.S. Food and Drug Administration (FDA) Device Good Manufacturing Practice Advisory Committee will meet to discuss and make recommendations on the current good manufacturing practice requirements for medical devices as part of an ongoing effort to more closely align U.S. Quality System requirements to other international standards.

FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”

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Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into devices. On December 23, 2021, the U.S. Food and Drug Administrations (FDA) announced the release of a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions,” to provide clarification … Continued

New Implementing Regulation Released to Provide Guidance on Electronic Instructions for Use (eIFU) under MDR

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On 14 December 2021, the European Commission published a new Implementing Regulation, (EU) 2021/2226, explaining the rules regarding the application of the Medical Device Regulation (MDR). Specifically, this document highlights the provision of electronic instructions for use (eIFU) for medical devices, which came into force on 4 January 2022.

European Commission Releases Further Harmonised Standards under EU MDR

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The New Year saw the European Commission (EC) publish a second batch of harmonised standards under the EU MDR. Commission Implementing Decision (EU) 2022/6, released on 4 January 2022, amends the earlier Implementing Decision (EU) 2021/1182 published in July 2021. It introduces a further nine harmonised standards that medical device manufacturers should reference to satisfy conformity requirements under the MDR.

FDA Issues COVID-19 Transition Plans for EUA and Enforcement Actions

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Following the declaration by DHS of the COVID-19 Pandemic, the FDA began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19). On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans.

FDA Releases 3D Printing at the Point of Care Discussion Paper

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Developing technologies in manufacturing, patient-matching and timely personalized patient care have identified the need to establish guidance and policy around the regulatory responsibilities of entities engaging in Point of Care (PoC) 3D printing. On December 10, 2021, the U.S. Food and Drug Administration (FDA) released a discussion paper regarding 3D printing medical devices at the … Continued

FDA Announces Release of “Playbook for Threat Modeling Medical Devices”

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On November 30, 2021, the U.S. Food and Drug Administrations (FDA) announced the release of a new playbook to assist medical device manufacturers in developing and evolving threat modeling approaches to strengthen the cybersecurity and safety of their products. The new “Playbook for Threat Modeling Medical Devices,” commissioned by the FDA and co-authored by MITRE Corporation … Continued

FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions

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In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop a draft revised version of “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”   

MDCG Publishes New Legacy Device Guidance 2021-25

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Following the release of the Medical Device Coordination Group (MDCG) guidance 2021-24 on 4 October, 2021, MDCG published additional guidance, MDCG 2021-25 Regulation (EU) 2017/745, dated 21 October, 2021.

MDCG Releases Guidance on Classification of Medical Devices (MDCG 2021-24

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On 4 October 2021, the Medical Device Coordination Group (MDCG) released the long-awaited guidance document (MDCG 2021-24) on classification of medical devices under MDR 2017/745.

FDA Breakthrough Devices and Safer Technologies Programs: Advantages for Patients and Medical Device Manufacturers

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Medical device and diagnostic manufacturers seeking acceleration of U.S. Food and Drug Administration (FDA) approval may benefit from one of two purpose-built FDA programs: 1) the Breakthrough Devices Program; and 2) the Safer Technologies Program (STeP). The benefits of these programs are substantial for manufacturers who apply, qualify and are granted designation by FDA.

May 26, 2021: Marking a Regulatory Milestone for EU Medical Device Manufacturers

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Today, the EU medical device industry reached a major milestone with the arrival of the extended application deadline for the European Union Medical Device Regulation (EU MDR 2017/745).

Star Tribune Interview with CEO, Christophe Berthoux: NAMSA in Growth Mode under New Leadership

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NAMSA, the Ohio-based medical device testing and consulting firm with a long history in the Twin Cities, is ratcheting up its deal-making following a transaction last year that put the company in new hands.

China State Council Releases Order 739, Creating New Market Access Opportunities for Global Medical Device and IVD Manufacturers

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China’s top administrative authority, the PRC State Council, issued the new regulation of Supervision and Administration of Medical Devices (or State Council Order Number 739) on February 9, 2021.

FDA Qualifies New Cybersecurity Medical Device Development Tool

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On October 20, 2020, the U.S. Food and Drug Administration’s (FDA) Medical Device Development Tools (MDDT) Program announced the qualification of a new tool for medical device development within cybersecurity risk evaluations.

MDCG Publishes New Guidance on Use of Standards Under MDR/IVDR

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On April 16, 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5).

Effective March 15: CMS Rule Regarding Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’

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On January 14, 2021, the Centers for Medicare & Medicaid Services (CMS) released the Final Rule, “Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary.” As part of Medicare’s Patients over Paperwork initiative, This final rule regulates how the largest U.S. federal payer will reimburse for innovative technologies, beginning March 15, 2021.

U.S. FDA Releases Artificial Intelligence and Machine Learning Action Plan

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In step with the U.S. Food and Drug Administration’s (FDA) commitment to develop and apply innovative approaches to the regulation of medical device software and other digital health technologies, on January 12, 2021, the Agency released their first Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD) Action Plan.

U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices

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In step with the Breakthrough Devices Program, and the Agency’s promise to introduce additional programs that promote earlier access to life-changing devices, the U.S. FDA introduced the Safer Technologies Program (“STeP”) on January 6, 2021. The FDA’s latest program is intended for 510(k), De Novo or PMA devices that do not meet Breakthrough Devices Program criteria, but still have an important role in the treatment of lesser life-threatening or debilitating diseases/conditions and bring significant benefits to patients.

NAMSA® Acquires Syntactx to Enhance End-to-End CRO Development Solutions, Expanding Medical Device Clinical Research Capabilities and Expertise

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NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of New York-based CRO, Syntactx. This acquisition follows independent healthcare investment firm ArchiMed’s majority interest purchase of NAMSA in September 2020.

New Guidance: Classification of IVD under the IVDR

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On 13 November, the Medical Device Coordination Group (MDCG) published their long anticipated IVD Classification guidance document for IVDR (MDCG 2020-16). The purpose of the document, “is to provide guidance to manufacturers, notified bodies and health institutions on how to classify an IVD prior to placing it on the market, making available on the market or putting into service in the Union.

CDRH COVID-19-Related Workload Impacts Q-Submission Reviews

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In recent weeks, NAMSA has become aware of instances in which the U.S. Food and Drug Administration (FDA) CDRH Office has closed Q-Submissions without review, citing resource constraints stemming from the COVID-19 Pandemic. With the FDA’s commitment to protecting public health, the agency has allocated resources to focus on COVID-19-related activities, working alongside other federal, state and local agencies and officials to address the pandemic.

Industry Update: Accreditation Scheme for Conformity Assessment

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As discussed in NAMSA’s December 19 blog post, “The Evolution of the Accreditation Scheme for Conformity Assessment,” ASCA is an assessment created by the U.S. Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).

FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

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On October 15, 2020, the U.S. Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological Evaluation of Medical Devices-Part 1: Evaluation and … Continued

Update: PMDA Review Timelines for Medical Device and IVD Products

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The Pharmaceutical and Medical Devices Agency (PMDA) is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan. One of the major functions of this agency is to review marketing applications of medical devices and in vitro diagnostic (IVD) products. In recent years, the PMDA has provided sponsors an annual report on review performance to assist in understanding the predictability and associated timelines for regulatory approval.

UKCA: A Wait and Watch Approach?

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On 1 September 2020, the gov.uk website published a new guidance document for manufacturers that place medical devices on the British market. Specifically, this document provides guidance on securing the UK Conformity Assessed (UKCA) mark from January 2021 onward.

Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

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With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

EU Commission Update : Notified Bodies Designated to MDR/IVDR

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With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

The IVDR Compliance Roadmap: From Start to Finish

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With the number of COVID-19 cases on the rise, and no definite end date to nationwide travel restrictions, various Contract Research Organizations (CROs) and Biotech/Pharma companies are hard at work trying to figure out how to efficiently conduct ongoing clinical trials while employees work remotely and subjects are restricted to their homes. Virtual options for clinical trials are gaining more clinical industry leader and regulator attention at this unique time in history. With the current technological resources available, Sponsors are able to conduct certain IVD clinical trials virtually with full regulatory compliance to FDA guidelines, and with several advantages.

European Commission Mandate for EU Parliament Negotiations on MDR Delay: Clarification Regarding Article 120(3)

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On 3 April 2020, NAMSA’s EU Regulatory experts provided a critique of The European Commission’s proposal to delay the date of MDR application. Since this time, the European Council provided feedback regarding the European Commission’s proposal to delay the date of application of certain provisions of Regulation (EU) 2017/745 on Medical Devices (MDR) by one year to 26 May 2021 in light of the COVID-19 Pandemic.

EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions

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Those involved in medical device design and development, quality and regulatory processes, and conformity assessments of medical products in the EU have rapidly diverted efforts to projects enabling increased production of essential medical devices such as ventilators due to the COVID-19 Pandemic. Understandably, the medical devices industry is unable to focus efforts towards the fast-approaching current date of application of Regulation (EU) 2017/745 on medical devices (MDR) of 26 May 2020.

FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions

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This week’s release of the U.S. Food and Drug Administration’s (FDA) final guidance on “Bone Anchors – Premarket Notification 510(k) Submissions” is based on the agency’s draft guidance from January 2017. While there are no significant differences between the draft document and the final guidance, the FDA did update this document to reflect other released guidance documents and minimal revisions.

U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process

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On February 27, 2020, the U.S. Food and Drug Administration (FDA) announced the launch of its new pilot program for 510(k) submission templates.

Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act

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TOLEDO, OHIO (BUSINESSWIRE) — January 7, 2019 — NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory testing, clinical research …

Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation

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The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) 2017/745 has introduced a number of Quality Management System (QMS) requirements for In Vitro Diagnostic (IVD) manufacturers.

The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval

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ASCA is the Accreditation Scheme for Conformity Assessment (ASCA), which was created by the United States Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA).

MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules

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As EU medical device manufacturers and sponsors scramble to meet Medical Device Regulation (MDR) conformity in just six months, a second draft corrigenda was published on 25 November 2019 that implements many new proposed changes benefiting some EU device makers.

Key Requirements of Post-Market Surveillance under IVDR

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As the new In Vitro Diagnostic Regulation (IVDR) replaces the current In Vitro Diagnostic Directive (IVDD) in 2022, there are many significant changes that IVD manufacturers must consider from a risk management perspective, as well as those pertaining to Post-Market Surveillance (PMS) to meet compliance.

IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand

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The European Union’s In Vitro Diagnostic Regulation (IVDR) 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC), introduces risk–based classification for IVD devices, in addition to new and required Technical Documentation. Specifically, the seven (7) classification rules under the IVDR have resulted in four (4) new risk groups for IVD products, which determine … Continued

MDCG Issues Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)

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On 26 September 2019, the Medical Device Coordination Group (MDCG) released final guidance regarding Summary of Safety and Clinical Performance (SSCP), which is intended to serve as a guide for medical device manufacturers and Notified Bodies under Medical Device Regulation (MDR) 2017/745. This guidance provides clear direction on the intent, content and structure of SSCPs … Continued

Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’

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In order to implement relevant requirements in the “Opinions on Deepening the Reform of the Examination and Approval System and Encouraging the Innovation of Drug Medical Devices,” the Chinese State Drug Administration issued the “Notice on the Implementation of Electronic Declaration of Medical Device Registration” (No. 46 of 2019) on May 31, 2019. Simultaneously, the … Continued

EU IVDR: Understanding the New QMS Requirements

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On 26 May 2017, the European Commission (EC) introduced the In Vitro Diagnostic Regulation (IVDR 2017/746), which replaces the current In Vitro Diagnostic Directive (IVDD 98/79/EC) and introduces major changes for IVD manufacturers throughout the European Union (EU). The IVDR: The Fantastic 4 (Systems) or 1 System for All? The IVDR clearly lays out that … Continued

FDA CDRH: New Organizational Structure Effective May 1, 2019

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In the fall of 2018, the U.S. Food & Drug Administration’s (FDA) Center for Medical Devices and Radiological Health (CDRH) announced the largest reorganization in years to initiate the Total Product Life Cycle (TPLC) approach across the institution (read more here). Fast forward to May 1, 2019—the date that the CDRH declared that it had … Continued

Draft Corrigenda for EU MDR and IVDR Released

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The EU Commission has released draft documents correcting aspects of the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. These drafts are currently under review by the EU Competent Authorities with comments expected by 20 March 2019. You may locate these documents by clicking on the links below: Draft Document for … Continued

EMA Issues Q&A Regarding Impact of MDR, Article 117

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Often overlooked, Article II7 of the European Union’s (EU) Medical Device Regulation (MDR 2017/745) lurks within Chapter X of the Final Provisions. However, this article is of high impact to market authorisation holders who provide medicinal products integral with administration devices. Specifically, it states that manufacturers of administrative devices must seek the opinion of a … Continued

EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit

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Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,” that described the consequences of the withdrawal of the UK from the EU as of 29 March 2019. This document explains the impact on Economic Operators and Notified Bodies, … Continued

UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario

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On the 24 January 2019, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) published contingency legislation which provides regulatory guidance for medicines, medical devices and clinical trials in the event that the UK departs the EU with no agreement on 29 March 2019. The Secretary of State, Stephen Hammond, also signed off on the … Continued

EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources

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The EU Commission’s website dedicated to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) planning has recently been updated, and now includes a new and dedicated page for preparation of the new regulations. This online resource, found here, includes a tool for stakeholders and Economic Operators to search for information specific to their … Continued

Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates

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The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. The compliance deadline of May 2020 may seem quite far away, but with a significant reduction in Notified Body capacity, a sizable increase in demand for regulatory certification services is … Continued

FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program

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Since May 28, 1976, the United States (U.S.) Food & Drug Administration (FDA) has had an alternative in place to the extremely burdensome Investigational Device Exemption (IDE) and Pre-Market Approval (PMA) processes to get new products onto the market, and that alternative is called the 510(k) process. By definition, “510(k) merely refers to the relevant … Continued

EU Commission & MDCG Release New MDR & IVDR Guidance Documents

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The first half of October experienced a (small) flurry of activity from key stakeholders implementing the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In addition, useful templates for Field Safety Notices (FSN) under the existing EU Directives (Active Implantable Medical Devices Directive [AIMDD], Medical Device Directive [MDD] and In … Continued

FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?

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The U.S. Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is currently undergoing one of its most ambitious reorganizations in decades to initiate the Total Product Life Cycle (TPLC) approach across the organization. The TPLC methodology, which has been in place in the Office of In-vitro Diagnostics and Radiological Health (OIR) … Continued

Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard

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Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within the European Economic Area (EEA), manufacturers must utilize the harmonized standard, EN ISO 14971:2012, to meet regulatory requirements. However, EU device manufacturers often struggle to … Continued

FDA Announces FY19 User Fees

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Today, the U.S. Food & Drug Administration (FDA) published its User Fees for Fiscal Year 2019 (October 1, 2018 – September 30, 2019), which includes pricing for device submissions and establishment registrations. The official notice from the FDA may be found by clicking here. The most significant changes for U.S. medical device manufacturers to consider are … Continued

EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR

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Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance has hindered manufacturers’ preparation to ensure they properly address new regulatory expectations by the mandatory conformity dates of May 2020 and May 2022, respectively. Fifteen … Continued

Mid-Year FDA Regulation & Guidance Review

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Introduction It is often difficult to stay abreast of the many regulatory changes occurring within the medical device industry, not to mention what they may mean in practice for global manufacturers. To assist with this mission, provided below is a mid-year review of noteworthy U.S. Food & Drug Administration (FDA) regulatory updates and guidance releases … Continued

FDA Issues New Draft Guidance Document for Pre-Submissions

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In response to the goals set forth within the 2017 Medical Device User Fee Amendment (MDUFA IV), the U.S. Food & Drug Administration (FDA) issued on June 7, 2018, a new Draft Guidance for Pre-Submissions, intended to replace the September 29, 2017 Final Guidance. Although the Draft Guidance, “Requests for Feedback and Meetings for Medical … Continued

EU MDR and IVDR Compliance Planning Resources

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The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and … Continued

CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR

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Introduction Increasingly, the world is engaged in conversations surrounding mobile and digital health applications. These types of platforms – broadly defined – encompass everything from pedometers, fitness apps, exercise diaries and even products that monitor health conditions such as diabetes, heart disease and depression. European manufacturers of such digital health technologies, medical applications and wearable … Continued

Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018

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On 31 January 2018, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released Cabinet Order No. 24 which sets forth changes for medical device and IVD registration user fees. These changes, which include increases from 8 to 15 percent, are effective 01 April 2018. To assist medical device manufacturers in assessing the impact of these changes … Continued

CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices

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On January 11, 2018, the China Food and Drug Administration (CFDA) issued “Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices.” These guidelines pertain to the acceptance of overseas clinical trial and evaluation data that are submitted by medical device and In Vitro Diagnostics (IVD) registration applicants in China. It is … Continued

EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”

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On 10 January 2018, the EU Commission issued the document, “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” While this notice does not contain information previously unknown to the UK government and medical device sectors, it does emphasize the implications of the failure of the UK … Continued

Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

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Introduction Within any industry, if you ask poor questions, you will often get poor answers. This is especially true for the medical device industry and more specifically, for product manufacturers seeking feedback from the U.S. Food & Drug Administration (FDA). Simply put, asking better questions can assist device organizations to identify and solve potential device … Continued

ISO 13485:2016 – Effective Preparation and Implementation of Medical Device Quality Management Systems

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Introduction The International Organization of Standards (ISO) is a worldwide federation of member bodies within a specific technical skill set that is responsible for the draft and release of global medical device regulations. In 1996, the ISO established guidance ISO 13485:2003 under the jurisdiction of the ISO / International Electrotechnical Commission (IEC) Directive, Part 1 … Continued

CFDA Releases “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft

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On October 31, 2017, the China Food and Drug Administration (CFDA) issued the “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft which aims to strengthen medical device technology reviews and approval systems. This draft guidance also further encourages medical technology innovation in light of the original guidance on “Opinions … Continued

Japan’s “Ninsho Kijun” Regulatory Approval Pathway

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Medical device products throughout the globe are characteristically classified by their specific risk level or category. This is no different in Japan, the world’s third largest medical device marketplace; however, there are important and very different considerations for manufacturers of Class II and III products in this territory than in any other part of the … Continued

Brexit and the Impact on UK Medical Device Operations

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On 23 June 2016, more than 30 million citizens in the United Kingdom (UK) voted in a referendum to determine whether the country should leave or remain part of the European Union (EU) – a political and economic union composed of 28 member states. The vote emerged victorious for the UK to depart the EU, … Continued

The Importance of Human Factors & Usability Engineering in Medical Devices

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Human factors principles have long been applied in high-hazard industries such as aerospace, nuclear, petrochemical, energy and transport in an effort to minimize potential risks. Increasingly, human factors in the life science industry have become recognized as an important topic. While human factors engineering was previously only accepted as necessary for electro-medical devices with complex … Continued

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

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On August 29, 2017, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published an interactive guide to assist Medical Device and In Vitro Diagnostics (IVD) companies with a comprehensive understanding of the new and different EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) requirements. The MDR and IVDR … Continued

New Medical Device Classification Catalog Issued by the CFDA

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At present, China has approximately 77,000 medical device registration certificates and 3.7 million medical equipment records, making the process of obtaining, tracking and managing classification documentation a rather large feat. On September 4, 2017, in an effort to simplify the classification process, the China Food and Drug Administration (CFDA) introduced a new version of the … Continued

The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy

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Introduction Medical device manufacturers have at their fingertips many types of clinical studies to demonstrate product safety and efficacy, one of which is a randomized, controlled pivotal trial. While there are many routes to initiate these types of trials, sponsors requiring such studies would be wise to first consider conducting a small randomized pilot study … Continued

Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval

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As any device manufacturer is aware, medical products throughout the globe are regulated according to each device’s targeted country of distribution. While conventional and/or equivalency products typically have a clearcut regulatory pathway, new or improved medical devices are often comprised of time-intensive and sometimes confusing regulatory approval routes. This is especially true for multinational manufacturers … Continued

EU MDR Poses Significant Changes for Importers and Distributors

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The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in the medical device distribution chain. The new MDR regulations differ significantly from the current EU Medical Device Directive (MDD) and go beyond design, development and … Continued

China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)

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On May 19, 2017, China’s State Council issued the “Supervision and Regulation of Medical Devices (No. 680),” just three years following the State Council Decree No. 650, which addressed similar regulations, including how medical devices should be supervised. While there are many parallels between the two regulations, there are three significant areas of change that … Continued

Risk: An Emerging Driver for New Regulatory Requirements

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Risk management is a relatively young management concept. During the last ten to 15 years, it has evolved from a technical economic discipline with roots in insurance, finance and engineering into a central theorem that has permeated regulatory and management domains. Increasingly, it is becoming one of the main topics of conversation, and marketplace catalyst, … Continued

MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden

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The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has prompted the implementation phase of this new and significant legislation. Its legal debut entitled, “Entry into Force,” follows 20 days after publication in the European … Continued