The Medical Device Regulations – Delayed, but not Derailed!

Currently, the medical device regulatory framework in the European Union is governed by Directive 90/385/EEC on Implantable Medical Devices, Directive 93/42/EEC on Medical Devices and Directive 98/79/EC on In-Vitro Diagnostic Medical Devices (the “Directives”). These are set to be replaced by The Medical Device Regulations and In-Vitro Diagnostic Device Regulations (“the Regulations”).

The Medical Device Regulations were set to become fully applicable and legally binding on 26 May 2020, with the In-Vitro Device Regulations becoming fully applicable and legally binding in May 2022. However, the current COVID-19 crisis, coupled with pre-existing pressures within the EU regulatory framework, has forced the European Commission to propose a delay to the application of the Medical Device Regulations until May 2021 with the In-Vitro Diagnostic Device Regulations remaining on track for full application on 26 May 2022.

The Regulations are designed to strengthen regulatory standards and to reflect the technological and scientific advancements which have been made since the Directives were enacted. The decision to strengthen standards emanated from, amongst other things, diverging interpretations of the current Directives by member states as well as a number of controversies including those surrounding the DuPuy metal hip replacement devices and PIP silicone breast implants.

Many within the medical device industry have been calling for a delay to the application of the Medical Device Regulations for some time. These calls have been prompted by the unprecedented pressures on the Notified Body network (who are responsible for certifying devices to be placed on the market) across the EU. Capacity from this network had been stripped by the rush to re-certify devices under the Directives before the expected May 2020 application of the Medical Device Regulations and by the need for notified bodies to achieve re-designation as notified bodies under the Medical Device Regulations.

The lack of capacity within the regulatory system had led industry players to warn that necessary medical devices could be pulled from the market in May 2020 due to the difficulties in having them re-certified for market under the Directives in advance of the application of the Medical Device Regulations.  The situation worsened significantly with the outbreak of the COVID-19 pandemic in Europe and across the world and the European Commission has now submitted a proposal to the European Parliament and Council to delay the application of the Medical Device Regulations by a year, until 26 May 2021. This proposal is expected to be adopted by the European Parliament and Council before the end of May.

The medical device regulatory framework across Europe is now almost entirely concerned with responding to COVID-19 and, despite the likely delay to the application of the Medical Device Regulations, capacity within the system remains severely depleted. Accordingly, now is not the time for economic operators within the medical device supply chain to become complacent in relation to their compliance with the Regulations. On the contrary, it is crucial that industry players use the additional time which they have been afforded to ensure a smooth transition to the MDR in May 2021.

While the delay of the application of the Medical Device Regulations will come as a welcome reprieve for many companies and provide additional for the design and implementation of an action plan for regulatory compliance, it is essential that this unexpected opportunity is embraced and capitalised on.

How we can help

If you have any queries or concerns, or would like to discuss the above in further detail or generally in relation to medical device regulatory compliance, please feel free to contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.