As under the current regulatory regime, manufacturers of in vitro diagnostic 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 IVDR has the same basic requirements as the previous Directive. It is generally more stringent than the Directive, 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 IVDR as from2022. 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 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.
Manufacturers can use the information and links below to draw up an action plan and start reviewing the classes their devices fall into under the IVDR.
