Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices

Two Commission Delegated Regulations concerning exemptions applying to some implantable devices and Class III devices were published in today’s Official Journal of the European Union, 19 June 2026. have just been published.

Article 52.4 of the MDR requires, with limited exceptions, that each Class IIb implantable device be the subject of an individual conformity assessment. Article 52.5 of the Regulation provides an exemption