Medical Devices Regulation (MDR)
The Medical Device Regulation (MDR) (EU 2017/745) published in May 2017, has replaced the Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices directive (AIMD) (90/385/EEC). After a transitional period, the full application of the MDR took effect in the spring of 2021. Kiwa Cermet Italia and Kiwa Dare Services (based in The Netherlands) have been designated a notified body for the MDR.
The MDR focuses on medical devices manufactured or sold in Europe. When the products meet all MDR requirements, they will be CE marked.
Key changes in MDR
The MDR differs significantly from the MDD, it contains a series of new requirements and key changes. 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 has changed regarding their role and responsibilities. Read more in this Kiwa Stories article.
According to the EU the new legislation brings a lot of improvements. Read more about the new regulations on medical devices on the EU website.