Full application of the new medical devices regime delayed to May 2021

In an earlier post, we discussed the EU Commission’s proposal to delay the start date of the new medical devices regulatory system for one year in order to take account of the current Coronavirus/COVID-19 pandemic. EU legislation to introduce a new regulatory system for general medical devices (the Medical Devices Regulation) was to have taken effect from 26 May 2020. However, a delay of 12 months was thought appropriate to reduce pressure on regulators and businesses, and to avoid interruption of medical equipment supply chains, during the crisis.

Delaying legislation in the form of a short amending Regulation has passed through the necessary procedures at lightning speed. The new system will become mandatory for general medical devices from 26 May 2021.

As well as putting back the date for full roll-out of the new system, the legislation provides support for emergency approvals of products necessary for combating the pandemic.

(Note that the new regulatory system for in vitro diagnostic medical devices is not due to apply until 26 May 2022.)

The delay may come too late for many producers, who will have been preparing for the change for some time. Indeed, it is already possible to adhere the new legislation when bringing new products to market.

The change is interesting in relation to Brexit, because (absent an extension) it takes the date of application of the Medical Devices Regulation beyond the end of the transition period. However, the UK has already indicated a commitment to implementing all key elements of the new systems in UK law. We can therefore expect the main structure of the new legislation to apply in the UK after Brexit, at least initially.

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