Medical Devices Regulation (MDR)
The Medical Devices Regulation (MDR) (EU 2017/745) published in May 2017 will replace the Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices directive (AIMD) (90/385/EEC). After a transitional period of three years, the full application of the MDR takes effect in the spring of 2020.
For medical device manufacturers the MDR is their number one concern, because they have to change many things to comply to this legislation. But also for Notified Bodies (NBs) a lot of changes regarding their role and responsibility take place.
Key changes in MDR
The MDR differs significantly from the MDD, it contains a series of new requirements and key changes. The new rules will improve market surveillance and traceability as well as make sure that all medical and in vitro diagnostic devices are designed to reflect the latest scientific and technological state-of-the art. The rules will also provide more transparency and legal certainty for producers, manufacturers and importers and help to strengthen international competitiveness and innovation in this strategic sector. (source: EU)
Read more about the new regulations on medical devices on the EU website.
What does the medical device manufacturer need to know?
What are important changes for NBs?