Team-NB encourages all members in line with this published report by CORE-MD group on “Conditional Certification for High-Risk Medical Devices”, to continually consider the possibility of issuing certificates with specific conditions, provisions, or limitations to ensure that innovative, novel and orphan medical devices continue to be accessible to healthcare professionals and patients in the EU with appropriate surveillance safeguards in place.
PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312