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FDA Releases Draft Guidance: Content of Premarket Submissions for Device Software Functions

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of Premarket Submissions for Software Contained in Medical Devices” (2005), the agency, on November 3, 2021, has issued draft guidance—“Content of Premarket Submissions for Device Software Functions.”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

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

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

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

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

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

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

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

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’

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

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

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

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

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

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

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

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

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?

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

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

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

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)

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

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

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

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

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

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

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

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

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

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)

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’

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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

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

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

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

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

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

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”

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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