MDR (Medical Device Regulation) is the new medical device regulation for Europe. It has been enforced since May 26, 2017. The MDR is valid inside all European member countries and replaces their previous national medical device legislation, as well as the former European Medical Devices Directive MDD (Medical Device Directive 93/42 / EEC). The transition period is 3 years.
For the first time: fully consistent requirements, a uniform audit protocol and a Europe-wide valid certificate are available for the approval of medical devices in Europe. For the medical device industry, MDR is a win for clarity, but also for obligations. The regulation of medical devices improves the requirements in some cases considerably, and for the first time, includes products without real medical purpose (such as purely aesthetic implants).
In parallel with MDR, the European Commission has also enacted a new regulation on in vitro diagnostic medical devices, IVDR (In-vitro Diagnostics Regulation).
As a manufacturer of medical devices, the new European medical device regulation requires a number of modified and additional measures before and after approval compared to the medical devices directive. We’ll keep you informed on our blog, on our website and in our training sessions. Teaching you everything you need to know about medical device regulation. Our experts will be pleased to assist you, so that you can quickly and completely succeed in the transition to MDR.
We summarized for you which key changes manufacturers of medical devices have to take into account compared to the former direction.