European Commission proposal to postpone Medical Devices Regulation until 26 May 2021
On 3 April 2020 the European Commission adopted a proposal to postpone the application date of the Medical Devices Regulation (MDR) (Regulation) for one year, i.e. until 26 May 2021. This decision was taken with patient health and safety in mind.
The proposal requires the full support of the European Parliament and the Council through an accelerated co-decision procedure and will enter into force on the day of its publication in the Official Journal of the European Union. The aim is to have the European Parliament and Council adopt the proposal before 26 May 2020, the date on which the MDR (EU) 2017/745 would become applicable.
The aforementioned postponement should take some pressure off national authorities, notified bodies, manufacturers and other actors so they can fully focus on urgent priorities related to the coronavirus crisis.
The proposal does not alter the Regulation on substance and does not impose new obligations on the concerned parties. It primarily aims to provide for a one-year deferral due to the exceptional reasons in the context of the current COVID-19 outbreak.
It was already unlikely that Member States, health institutions, economic operators and other relevant parties would be able to ensure the proper implementation and application of the Regulation as from 26 May 2020. However, due to the unprecedented magnitude of the current COVID-19 challenges, proper implementation became even more unlikely. The COVID-19 crisis has created extraordinary circumstances that demand a substantial amount of additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated at the time of adoption of the Regulation.
Furthermore and in order to ensure the continuous presence of a functioning and effective regulatory framework for medical devices, the proposal aims to defer the application of the provision repealing the currently applicable Directives on (Active Implantable) Medical Devices 90/385/EEC and 93/42/EEC (Directives). The Regulation should therefore be amended accordingly. Further the proposal allows for the extension of the validity of national derogations, authorized under the Directives. For example the fact that a competent authority may authorize, on a duly justified request, the placing on the market a specific device for which the applicable procedures referred to, have not been carried out, but use of which is in the interest of public health or patient safety or health. Such as marketing non-CE marked devices in times of COVID-19 for example. Please refer to our earlier LS-article we wrote about this subject. For our earlier publication (in Dutch) about cooperation with regard to the purchase of medical devices, please refer to this link.
The proposal will not affect the date of application of the In Vitro Diagnostics Medical Device Regulation, which will be applicable as from 26 May 2022 (EU) 2017/746.
Should you have any questions about your specific case, please do not hesitate to contact Aurélie Mingels or you regular Loyens & Loeff advisor.