Go to Client Portal
NAMSA

Best Practices for MDR-Compliant Clinical Evaluations

Learn how to align clinical evaluations with MDR in our guide, featuring NAMSA’s expert insights and auditor feedback for medical device manufacturers.

Navigating the New MDCG Guidance Documents on CIP and IB

Discover key insights on the latest MDCG guidance for EU medical device clinical investigations, aiding in compliant CIP and IB development.

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

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

MDR Vigilance: New MDCG Guidance Published

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

European Commission Updates Chemical Classification and Labeling

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

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

MDCG 2021-6 Rev 1: Clarifications on Clinical Investigations

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

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

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

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

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.

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

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

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

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.

UK MHRA Advisory Group Publishes Proposals

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

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.

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

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)

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

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.

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

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

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

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?

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

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). 

New UK MHRA Medical Devices Regulations Published

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.

MDCG 2022-8: Clarification of IVDR Requirements for Legacy Devices

The MDCG 2022-8 is probably one of the most important IVDR guidance documents that has been published in recent months as it finally clarifies what requirements are/are not applicable to legacy IVDs post-IVDR Date of Application (26 May 2022). This guidance discusses: 1) requirements within Chapter VII for post-market surveillance; 2) market surveillance/vigilance for “legacy devices”; 3) other IVDR requirements for “legacy devices”; and 4) IVDR requirements for devices placed on the market prior to 26 May 2022 (“old devices”).

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

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).

New MDCG 2022-4 Guidance Released

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.

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

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

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.

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.

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).

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).

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.

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.

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.

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.

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.

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

NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany

Tuesday, October 8, 2019–FRANKFURT, Germany–(BUSINESS WIRE)–NAMSA®, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research, and reimbursement and regulatory consulting services, is pleased to announce that it has been awarded DIN EN ISO/IEC 17025:2018 accreditation by DAkkS. DAkkS, the sole national accreditation body for the Federal Republic … 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

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

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

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

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

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

NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe

28 FEBRUARY 2018 – LYON, FRANCE – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services, is pleased to introduce its newly launched French language website. The release of this online resource comes as a result of significant, increased demand … 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

NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development

The world’s only Medical Research Organization brings 50 years of testing leadership to Germany with new Analytical Services Laboratory. FRANKFURT, GERMANY – February 1, 2018 – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated testing, clinical research and regulatory consulting services, is pleased to announce the launch of … Continued

NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace

October 31, 2017 – FRANKFURT, Germany – (BUSINESS WIRE) – NAMSA®, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting services is pleased to announce the launch of its newly developed German language website. The introduction of this highly-anticipated online resource will help support medical product … 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

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

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

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