Fimea has approved the first notified body under the new Medical Devices Regulation (MDR), SGS Fimko Oy, in Finland.
One of the most significant requirements for medical device legislation is to re-evaluation and designate the notified bodies. Notified bodies play a key role in assessing the conformity of high-risk medical devices prior to their marketing.
The designation requires a detailed evaluation of the application, extensive investigation work, co-evaluation by EU authorities and final approval from the Medical Device Coordination Group formed by the Commission and other Member States.
Access to the services of notified bodies is a critical factor in bringing new innovative devices to market. Not more than 19 notified bodies have been designated so far in EU.