Medical devices: New information on implant card and person responsible for regulatory compliance

• Manufacturers of an implantable device shall provide information for identification of the device on an implant card in accordance with Article 18 MDR. More detailed guidance on a uniform format of an implant card have now been published on the website of the European Commission.
• According to MDR/IVDR, manufacturers and authorised representatives shall have available within their organisation a person responsible for regulatory compliance (PRRC). The requirements and responsibilities as well as the employment relationship of the PRRC are defined in Article 15 MDR/IVDR. For further clarification of these requirements, a guidance document has been published on the website of the European Commission.

Further information on these publications can be found on the following BASG website:

https://www.basg.gv.at/medizinprodukte/mdr-ivdr/aktuelles-zu-mdr-ivdr/