NAMSA Guide: EU MDR & IVDR Regulation Tool

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]).

Given the absence of Bookmarks and a Table of Contents within the new Regulations, the MDR and IVDR can be difficult to navigate. NAMSA has created a Regulation Tool to allow for efficacious planning to meet the mandatory compliance dates of May 2020 (MDR) and May 2022 (IVDR).

Provided within this document are:

• 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

We hope that you find this enhanced copy of the Regulations to be a beneficial resource as you prepare for implementation of MDR/IVDR.