European Commission Expands List of Class IIb Implantable Devices Exempt from Individual Technical Documentation Assessment
The European Commission expands the list of Class IIb implantable devices exempt from individual technical documentation assessment under MDR Article 52(4).
European Commission Expands MDR List of Devices Exempt from Clinical Investigations
The European Commission expands the list of implantable and Class III devices exempt from clinical investigations under MDR Article 61. Key regulatory update for manufacturers.