The Medical Device Coordination Group (MDCG) has issued a new guidance document MDCG 2021-1, Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional. The document seeks to provide clarification in a highly ambiguous scenario.
Numerous references in Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are related to EUDAMED and new and comprehensive registration procedures.
EUDAMED was planned as a central and integrative tool for increased transparency and market surveillance under the MDR and IVDR regime. Current plans provide for a full availability of the database by May 2022. The actor registration module has been made available in December 2020 while the remaining five modules will be introduced gradually.
This has led to a high degree of confusion among economic operators – uncertainty exists for example around questions related to the deadlines for manufacturer and device registrations, but also with regards to the applicability of UDI requirements.
MDCG 2021-1 attempts to give answers at least to some of these questions. For example, the document says:
- Independently from the delay of device registration requirements, the overall UDI requirements apply for all manufacturers who aim to declare compliance to the MDR as of May 26, 2021.
- For class III and implantable devices the Summary of Safety and Performance shall be made available to the public upon request or manufacturers should specify where the summary is made available.
- Periodic Safety Update Reports set up by manufacturers of class III or implantable devices should deliver the reports to the Notified Body by appropriate means.
- Serious incident reporting should be done to the respective national competent authorities with the new MIR form. FSCAs including FSNs, PSRs and trend reports should use the current form with additional information as required by the MDR added in the report. All items will have to be provided to the concerning national competent authorities.
We recommend to review the guidance document in addition to reading this article as we have only mentioned the main aspects. The full document can be found here.
Source: European Commission