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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