Medical devices: New information on implant card and person responsible for regulatory compliance
messages in brief | 17/07/2019
- 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:
Page last modified: 17/07/2019