UPDATE: April 27, 2020: A 13th notified body has been designated under the EU Medical Device Regulation, per a listing published in the European Commission's NANDO database on Saturday. German firm mdc medical device certification GmbH is the first new notified body to be authorized for either MDR or IVDR-related business in over a month. The latest addition builds on Germany's lead for number of notified bodies designated against the incoming Medical Device Regulation; there are now five based in Germany, three in the Netherlands, and one apiece in Ireland, Italy, Norway, Hungary and the U.K.
- With its publication Friday in the Official Journal of the European Union, the one-year postponement to the go-live date for the EU Medical Device Regulation and extension of validity of the Medical Device Directives became a done deal.
- The important final step for the extraordinary measure came with just over a month to spare before the regulation would have taken force, and almost exactly a month after the European Commission announced plans to introduce the delay in light of disruptions from the coronavirus pandemic. The Parliament and Council nearly unanimously greenlighted the postponement.
- Separately, the Medical Device Coordination Group (MDCG) posted four new documents Friday aimed at clarifying clinical investigation and evaluation for notified bodies and manufacturers.
The past month has been marked by cautious optimism that a formal MDR delay would speed through the necessary regulatory path prior to the original May 26 start date. Now that the measure, which regulators said was needed to allow medtech manufacturers to focus on meeting market demands driven by the "unprecedented magnitude of the current challenges," has been officially recorded in the EU journal, industry can breathe a collective sigh of relief.
"In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption, it is necessary to defer the application of certain provisions," the amendment to legislation states.
It also says: "Taking into account the COVID-19 outbreak and the associated public health crisis, the Commission should be able to adopt Unionwide derogations in response to national derogations in order to address potential Union-wide shortages of vitally important medical devices in an effective manner."
Still, the one-year delay doesn't solve the challenges for the relatively few notified bodies designated for MDR work. However, to avoid further bottlenecks, the MDCG is permitting notified bodies to conduct remote audits during the coronavirus outbreak.
The industry is also still waiting on other guidance from regulatory authorities. To that end, MDCG published a postmarket clinical follow-up plan and evaluation report template guides for manufacturers and notified bodies, as well as guidance on clinical evidence needed for medical devices previously CE marked under the Medical Device Directives and demonstrating equivalence.
Regulators have made it clear to date that despite their willingness to delay MDR enforcement, the In Vitro Diagnostic Regulation will still take force in 2022. Industry group MedTech Europe is arguing that IVD manufacturers, many of which are focused on rapidly getting novel coronavirus diagnostics to market, are also in need of more time to comply with the forthcoming regulatory overhaul.