Long-lasting relationships with notified bodies (NBs) are important and also business critical for many medical device manufacturers.
Why? Because the higher risk class medical device (Is, Ir, Im, IIa, IIb, III) manufacturer needs to involve NBs as third-parties in the conformity assessment when accessing and selling devices on the EU markets. As a part of this conformity assessment, an NB assesses the medical device manufacturer’s quality management system by conducting annual audits and its technical documentation by TD reviews.
To place devices on the EU markets, a device manufacturer needs to select a suitable conformity assessment route defined by the Medical Device Regulation (MDR). If NB involvement is needed, the manufacturer needs to apply to an NB. The device manufacturer may apply to an NB of its choice, provided that the chosen NB is designated for conformity assessment activities related to the types of devices concerned.
When an NB receives an application from a manufacturer, the NB will evaluate if the devices belong to its scope of designation. If the products do not fall under MDR and the scope of the NB’s designation, the NB is not able to perform conformity assessment and will reject the application.
Currently, there are 22 NBs that are designated under the MDR, of which two are located in Finland; Eurofins Expert Services Oy and SGS Fimko Oy.
Recently, there has been a lot of debate about the capacity concerns related to NBs because the number of designated NBs under the MDR is still low when compared to NBs designated under the Medical Device Directive, meaning that there are less NBs available to provide services within the rapidly developing business field. In addition, there are new designation codes under the MDR which did not exist under the Directive. These scenarios might mean to device manufacturers that they need to change the NB when transforming products under the MDR or they might need to stop sales in the EU until the conformity assessment has been completed. To ensure smooth access to the EU markets, a well-planned and structured strategy is needed.
DRA’s Health Technology team will help your company create a strategy to enable smooth access to EU markets under the MDR. Also, if needed, DRA’s Health Technology team will provide support when applying for conformity assessment from an MDR notified body.