There are new requirements established by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) including expanded clinical evidence requirements, more regulatory oversight, additional requirements for IVD manufacturers, and stricter supervision of Notified Bodies.
To help guide companies through what may be a challenging process of navigating the new regulations, a number of documents have been compiled by NAMSA and are available for review.
They include:
Guidance Documents
- 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
White Papers
- 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
Webinars
- 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
- 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)
While not exhaustive, this should list provide a helpful guide for device manufacturers required to re-certify their products in the EU.
