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 to ensure conformity to MDR (mandatory compliance as of May 2021) and May 2022 for IVDR.
For some clarity, the EU MDR was created to oversee the production and distribution of medical devices that come into direct contact with the body. EU IVDR regulation, on the other hand, involves in vitro diagnostic products, taking specimens from the body and analyzing them outside of the body. Both EU MDR and IVDR regulations have their own separate thresholds and covered substances.
NAMSA, in an effort to assist global medical device and IVD manufacturers with their compliance planning, has made available several complementary 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