Notified bodies play a significant role in helping medical device manufacturers bring new products to the EU market. Their primary responsibility is to conduct conformity assessments and grant CE certificates for devices.
This involves auditing the manufacturer’s quality management system (QMS) and reviewing the technical documentation for the different classes of devices. To issue CE certificates, notified bodies must be recertified and designated according to the new IVDR. The goal is to identify the notified bodies that are truly qualified to ensure the safety and effectiveness of the products that they are evaluating. Starting on November 26, 2017, notified bodies were able to submit applications to become designated under the IVDR. A complete listing of the notified bodies that are officially designated is maintained on the NANDO (New Approach Notified and Designated Organisations) database.
Under the IVDR, notified bodies will take on more responsibility in enforcing regulations through annual on-site assessments as well as unannounced audits of manufacturing processes, subcontractors, and suppliers.
The number of notified bodies has decreased significantly due to the new designation requirements3. This will most likely impact manufacturers’ timelines for product certification as resources become more stretched.