As under the current regulatory regime, manufacturers of medical devices take prime responsibility for getting their products CE-marked for the European market. Now, they need to manage the change to get their products CE-marked under the new Regulation.
The MDR has the same basic requirements as the 2 previous Directives. It is generally more stringent than the Directives, especially in terms of risk classes and the oversight provided by notified bodies (NBs). There is also more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring (‘vigilance’ and ‘post-market surveillance’).
The manufacturers will have to comply with the MDR by May 2021. It’s important to start the transition as soon as possible. The Regulation allows for transitional provisions if more time is needed due to the
- high number of devices on the market
- anticipated bottleneck in reviews by notified bodies
- ongoing need to interpret certain provisions of the Regulations
An early start is especially important because of the expected pressure on notified bodies during the transition period. Approach the chosen NBs as soon as possible. Check whether they intend to apply for designation under the new Regulation, including the scope they intend to cover, and when they think they will be ready.
The information below will help manufacturers to comply with the Regulation such as factsheet and step-by-step guide. It includes links from third parties such as the Competent Authorities for Medical Devices (CAMD).
Manufacturers are encouraged to draw up an action plan and prepare the MDR.