AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents

MDR and IVDR guidance: Tracking the MDCG’s progress towards its goals

• Europe enacted the medical device (MDR) and IVD regulations (IVDR) in May 2017 but gave manufacturers and other stakeholders, including the regulators themselves, time for implementation. The Regulations were incomplete as first published, with the use of placeholders where implementing regulations would – or could – be put in place down the road. There was also a need for a raft of new guidance documents to help stakeholders operationalize the regulations, as the old documents no longer applied. Over the course of the last six years, the Medical Device Coordination Group (MDCG) and its subgroups have turned out well over 120 guidance documents to help stakeholders act on the Regulations.
• In light of the many guidance documents that needed to be developed to match the new Regulations, the MDCG created a list to identify planned guidance (both new documents and revisions) and anticipated endorsement dates: Ongoing guidance development and deliverables (last updated March 2024). However, the annual update to this list does not acknowledge changes to the previous plans or publication delays, nor does this list appear to be all inclusive. By reviewing meeting agendas and minutes, other European Commission and MDCG publications, and various webinars, AgencyIQ is now aware of multiple other new documents and revisions that are currently in progress. [ See AgencyIQ’s analysis of MDCG guidance publications since 2017 here.]

What has the MDCG published recently?

• Below are the eight documents published so far in 2024. Note: One was published by the European Medicines Agency (EMA), which took over certain device oversight as part of its expanded remit for public health emergencies:

• Here are the seventeen documents that the Commission or the MDCG published or revised in 2023 (not all were part of the ongoing guidance development and deliverables document):

Which documents officially tracked on the MDCG list remain outstanding?

• The MDCG updated its list of ongoing guidance documents in March 2024, including a total of 47 items. None of these items have been published to date. Of these, 43 items are planned for 2024, one is planned for 2025, one is listed as continuous, one is listed as TBD, and the last is “as needed.”

What other documents are currently in the works, according to meeting agendas, webinars and publications?

• AgencyIQ is currently aware of 7 additional guidance documents (1 new, 6 revisions) that are currently in process or being discussed in MDCG meetings or elsewhere (source indicated):

To contact the author of this resource, please email Corey Jaseph ( [email protected]).
To contact the editors of this resource, please email Chelsey McIntyre ( [email protected]).