Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN

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The Medical Device Coordination Group (MDCG) has issued new guidance documents under Regulation (EU) 2017/745 on medical devices (MDR):

  1. MDCG 2021-08 lays out application mechanisms including application forms for clinical investigations. These are to be used in the absence of EUDAMED as a central registration platform for clinical studies. The included forms are aligned as far as possible with the planned EUDAMED data fields.
  2. MDCG 2021-09 specifies UDI requirements for manufacturers of contact lenses, spectacle frames, spectacle lenses and ready readers. Among others, manufacturers are reminded that they must set up the UDI system as per MDR requirements. Furthermore, manufacturers of the aforementioned products should not use the voluntary UDI/ device registration in EUDAMED until further notice. 
  3. MDCG 2021-11 on implant cards is complementary to MDCG 2019-8. The guidance provides a non-exhaustive list of implantable medical device types to aid manufacturers allocate the appropriate term allowing the identification of the device on the implant card.
  4. MDCG 2021-12 can be cross-referenced to our article from our May newsletter on the EMDN website. The guidance provides FAQ and answers on the new European nomenclature system

Should you have any questions or concerns, please don’t hesitate to get in touch. We are also happy to provide you with the corresponding guidance documents.

Source: European Commission

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