Preparing for the New EU Medical Devices Regulation (MDR)
The EU’s Medical Devices Regulation (MDR) came into force on 25 May 2017. This legislation replaces the EU’s current Medical Device Directive (MDD), namely 93/42/EEC and 90/385/EEC (active implantable medical devices). We are now in the transition period where both legal frameworks can be applied. Below we have outlined some important information about this regulatory change.
What is the new MDR, and what are the key differences between it and the MDD?
The MDR will replace the MDD and it applies to all medical device manufacturers who have goods for sale on the European market. It is important to note that no existing requirements have been removed from the MDD, but the MDR does add new requirements, for example:
- Expansion of the scope of products covered
- Reclassification of devices according to risk
- More rigorous requirements for clinical evidence and evaluation
- Mandatory implementation of unique device identification measures
- Increased post-market oversight by EU notified bodies.
Compared to the current directive, the MDR places more emphasis on a life cycle approach to safety, backed up by clinical data. The MDR also presents more stringent requirements for the designation of notified bodies, with increased control and monitoring by the national competent authorities and the European Commission.
What are the key deadlines?
- 26 May 2020: New devices and existing devices without an MDD/AIMDD certificate must meet MDR requirements.
- 27 May 2024: Devices may only be marketed under MDR certificates.
- 27 May 2025: Devices with an MDD certificate may no longer be sold.
What is Medline doing to prepare?
Unique device identification measures are already in place, and updates to labelling and our quality management system have begun.
This year and for the next two years, Medline is focusing on updating all of our technical files (class I, IIa and IIb, sterile and non-sterile) to the MDR. We have also started to contact the suppliers of our SPT components to ensure that they are working on attaining proper certificates.
In 2022, we plan to have all Medline devices registered in the European Databank on Medical Devices (EUDAMED). Our goal is to have all MDR certificates in place by 2023, one year ahead of schedule.