Under the new IVDR, an estimated 80% of devices are expected to require Notified Body involvement as opposed to 20% under the MDD.
Devices will be categorised according to their risk levels which in turn determines their conformity assessment routes. All devices, except those in the Class A category, will require several key documents to demonstrate compliance. These include technical documentation, as well as the European Union (EU) declaration of conformity which needs to be drawn up in respect of the devices placed on the market.
This means that Notified Bodies will be required to certify various aspects of Class B, C and D (medium to high-risk) devices before they enter the market.
Additionally, manufacturers will also need to conduct post-market surveillance to check the safety and performance of these devices afterthey are placed on the market.
To find out what these changes mean for your organisation and what are the measures you could take, download the LRQA Technical Documentation Review PDF.