As part of the CE Marking process and the corresponding conformity assessment procedure, manufacturers must draw up a Declaration of Conformity. In simple terms, the Declaration of Conformity is the manufacturer’s formal declaration that the devices listed on the document are in conformance with the medical devices Directives or Regulations respectively.
It is a highly official and legally binding document that should only be signed by a senior officer.
The Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) stipulate certain contents that must be included, e.g.:
- Manufacturer and EU Authorized Representative details including SRN
- Basic UDI-DI
- Product details
- Risk class and rule(s)
- Notified Body and Notified Body certificate details
- Conformity assessment procedure
- Formal statements and contents
Do you need assistance in setting up your Declaration of Conformity? mdi Europa can assist with valuable insights and may also provide a template. Please contact us for further information.