The European Commission on Friday released a proposal that would defer for a year the Medical Devices Regulation (MDR) from taking effect on 26 May.
With an eye toward avoiding the disruption of the device market at such a critical time, the year-long delay will not alter the substance of MDR. The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation,” the commission said.
Stella Kyriakides, Commissioner for Health and Food Safety, said in a statement: “Our priority is to support Member States to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.”
The proposal also notes the complexity of MDR, adding that “it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as it provides for.”
Derogations
The proposal also calls for certain MDR-related transitional provisions to apply even though they would otherwise not apply under the Medical Devices Directive (MDD) and other directives.
For instance, the proposal says the commission should adopt EU-wide derogations in response to national derogations in order to address potential device shortages. Derogations allow national authorities to place certain devices on the market even if the conformity assessment procedures have not been carried out yet.
“It is for this reason appropriate that the relevant provision of Regulation (EU) 2017/745 applies at the earliest date possible and that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC [Medical Devices Directive] are repealed from that same date,” the proposal says.
The proposal also seeks to defer the application of the provision repealing MDD. As for the In Vitro Diagnostics Regulation (IVDR), which will be applicable from 26 May 2022, the commission said there will be no changes with its timeline.
The proposal still needs the support of the European Parliament and the Council through an accelerated co-decision procedure, the commission said.
Guidance
In addition to the proposal, the commission also released a Q&A guidance on Friday on medical devices within the context of COVID-19.
It discusses placing devices on the market, standards used, standards relevant to COVID-19, off-label use of devices and more. A standards checklist from the International Medical Device Regulators Forum (IMDRF) was also released.
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