MDR/IVDR Guidance: MDCG Explains What’s Coming

Regulatory NewsRegulatory News | 25 October 2019 |  By 

The European Commission’s Medical Device Coordination Group (MDCG) on Friday unveiled its plans for releasing almost 50 future guidance documents related to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR), with the bulk of the new guidance coming on the oversight of notified bodies (NBs) and clinical investigations and evaluation (CIE).

The list also notes that much of the guidance will be endorsed by the MDCG later this year or in 2020, although for more than 20 guidance documents, the timing is to be decided.

So far, the group has released guidance on NBs, Eudamed, Article 54(2) of MDR, transitional provisions, a new summary of safety and clinical performance, persons responsible for regulatory compliance and others.

As questions linger on NB capacity, guidance documents coming later this year or in 2020 and related to NB oversight will include: Sampling of devices on a representative basis, an explanatory note on codes and further questions and answers on NBs. Additional NB guidance coming at an undetermined date will focus on batch verification on class D IVDs, significant changes and the applicability of the clinical evaluation consultation procedure under MDR.

And a guidance for NBs on the International Medical Device Regulators Forum’s Medical Device Single Audit Program is also expected at a later date.

More guidance on the clinical investigation application and assessment template is coming later this year, as well as forms for reporting serious adverse events, among other CIE guidance.

MDCG guidance on the market surveillance for Class I devices is also coming in 2019, which will be of particular interest to those that submitted a proposal to the European Commission for a second corrigendum to change the timetable for Class I reusable devices, including some software, that are being upclassified. Other guidance on authorized representatives is coming in 2020, according to the MDCG.

As far as new technologies, guidance on the clinical evaluation of software is coming this year and guidance on cybersecurity is coming at a later date.

Two unique device identifier (UDI) guidance documents will be released later this year, including one on the integration of UDIs into manufacturers’ quality management systems and one on contact lenses as part of cooperative work with US regulators.

For IVDs, guidance is coming later this year on classifications, the MDCG says, but other documents on the qualification of assays used in clinical trials of medicinal products and performance evaluations, among others, are coming at a later date.

A half-dozen nomenclature guidance documents will also be released by the MDCG, but the only one expected this year is on terms to be used for implant card purposes.

Ongoing Guidance development within MDCG Subgroups


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