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, sets 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 intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).
These lengthy documents can be cumbersome to navigate, particularly when trying to understand how the new regulations compare to the previous directives—and more importantly, the critical steps that manufacturers should undertake now to ensure conformity by May 2020 (MDR) and May 2022 (IVDR), respectively.
NAMSA, in an effort to assist global medical device and IVD manufacturers with their compliance planning, has made available several complimentary resources which can be found below.
We hope you find these tools to be beneficial as you prepare for implementation of the new regulations.
In July 2018, the EU Commission issued the following “Information to Manufacturers” in an effort to provide further clarity on new regulatory changes and implementation models to address the regulations:
- Draft Functional Specifications for the European Database on Medical Devices (Eudamed) – First Release
- Exhaustive List of Requirements for Manufacturers of Medical Devices
- Implementation Model for Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of Medical Devices
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
- Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
- Field Safety Notice (FSN) Guidance Documents
- IVDR Readiness Guide: A Resource to Assist Global Manufacturers in their Preparations for Compliance to IVDR by May 2022
- How to Select the Proper EU Notified Body for your Medical Device Organization
- Regulation Tool: European Union’s MDR and IVDR (Cross-Referenced and Bookmarked Resource with Fact Sheet)
- White Paper: Leveraging Post-Market Surveillance and Post-Market Clinical Follow-Up Data to Support EU MDR Compliance
- Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management
- MDR 10.4.1: What Should we be Doing to be Prepared?
- How to Select the Right EU Notified Body for IVDR Compliance
- IVD Clinical Trials: Essential Components for Product Launch in 2019 and Beyond
- EU MDR: General Safety & Performance Requirements for the Biocompatibility of Medical Devices
- EU MDR: Optimizing Clinical Evaluation Reports (CERs) within the Medical Device Lifecycle
- Leveraging Post-Market Surveillance & Clinical Follow-Up Data to Support EU MDR Compliance
- EU IVDR: Top 5 Changes for Medical Device Manufacturers to Consider
Regulatory Pulse Blog
- MDCG Issues Guidance on Summary of Safety and Clinical Performance under the MDR (October 2019)
- EU IVDR: Understanding the New QMS Requirements (July 2019)
- Draft Corrigenda for EU MDR and IVDR Released (March 2019)
- EMA Issues Q&A Regarding Impact of MDR, Article 117 (March 2019)
- EU Commission Updates Website to Provide Additional MDR & IVDR Planning Resources (Jan. 2019)
- Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates (Jan. 2019)
- EU Commission and MDCG Release New MDR/IVDR Guidance Documents (Oct. 2018)
- CE Marketing of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR (April 2018)
- UK MHRA Publishes Guide to the New EU MDR AND IVDR (Sept. 2017)
- EU MDR Poses Significant Changes for Importers and Distributors (July 2017)
- MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden (April 2017)
How can NAMSA Help?
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new EU MDR and IVDR regulations, including the critical steps you should be taking now to realize successful outcomes.