It is no longer a secret that the new EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) pose a great regulatory challenge. With the entry into force of these new regulations, products already placed on the market must also be re-certified subsequently. But at present, there are not enough Notified Bodies to carry out the certification, considering the number of existing medical devices in relation to the number of Notified Bodies. In the EU, there are 33 Notified Bodies designated for the MDR and only seven Notified Bodies designated for the IVDR. This illustrates the need for Notified Bodies.
The problem is commonly known so that recently, there have been repeated warnings that those medical devices whose manufacturers are unable to find a Notified Body will have to be withdrawn from the market at the end of the transitional period. In order to prevent this, several industry associations have called for an extension of the transitional period, but the European Commission has not yet taken a positive stance on this. However, the Medical Device Coordination Group (MDCG) was tasked with proposing solutions to address the capacity problem. The resulting MDCG guidance 2022-14 recognizes the urgent challenges and encourages an efficient approach to meeting regulatory requirements. The MDCG suggests several solutions to alleviate the bottleneck. One promising proposal to increase the capacity of Notified Bodies is, for example, the use of hybrid audits. Another crucial point is to increase the readiness of manufacturers, whereby the MDCG calls on manufacturers not to wait until the end of the transitional periods, and on Notified Bodies to assist with concrete guidance, including information on the preparation and content of the technical documents. a&r strongly recommends that all manufacturers seek for certification timely, and will be happy to assist with the documentation and compilation of the required files. Please do not hesitate to contact us for support with the certification of your substance-based Medical Device or In Vitro Diagnostic Medical Device.