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 increased supervision of Notified Bodies (NBs) are just some of the major changes to be considered as compared to the EU’s previous Directives (Active Implantable Medical Devices [AIMD], Medical Device Directive [MDD] and the In Vitro Diagnostic Directive [IVDD]).
However, given the absence of organizational planning tools such as Bookmarks and a Table of Contents within the new Regulations, the MDR and IVDR can often be difficult to navigate for global medical device manufacturers. NAMSA, in an effort to assist device firms in their planning to meet the mandatory compliance dates of May 2020 (MDR) and May 2022 (IVDR), has published an enhanced Regulation Tool that provides:
- Bookmarks for each Article and Annex
- Links to where the Regulation references another section of the document
- Links to other cited Regulations, Directives, documents or websites
- European Commission Fact Sheet
Please click here to access NAMSA’s Regulation Tool.
Additionally, NAMSA also has the following resources available for EU MDR and IVDR preparation:
- Blog Posts:
- Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
- CE Marketing of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
- UK MHRA Publishes Guide to the New EU MDR AND IVDR
- EU MDR Poses Significant Changes for Importers and Distributors
- MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
We hope that you find these resources to be a beneficial as you prepare for implementation of the new Regulations.
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.
Barb has over 25 years’ experience within the medical device industry, holding various executive and management positions in regulatory, clinical affairs and quality systems. She has authored over 70 FDA submissions, conducted 40+ international product marketing and registration applications, and developed nearly 45 global regulatory assessments and strategies. Barb currently serves as Principal Medical Research Scientist (Regulatory) at NAMSA.