The European Commission has proposed to postpone the application of the EU Medical Device Regulation (“MD Regulation”) by one year. The intention is to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic, without needing to worry about their obligations under the new MD Regulation.
What is the MD Regulation?
The MD Regulation is a response to perceived short comings in the EU’s existing medical regulations, and represents an overhaul of the current regulatory framework. The changes brought about by the MD Regulation are extensive e.g. widening the scope of what constitutes a ‘medical device’ and requiring all medical devices to carry a ‘unique device identifier’. For more information regarding the changes brought about by the MD Regulation, please see our article explaining them here.
What is proposed?
The European Commission has proposed that the date by which the MD Regulation becomes fully applicable is delayed by one year from 26 May 2020 to 26 May 2021. In turn, the Commission have proposed deferring the repeal of existing regulation, namely the EU Directive on Implantable Medical Devices, and the EU Directive on Medical Devices (together the “Existing Regulations”), by one year. Such a proposal will no doubt be welcomed by the industry, with MedTech Europe and the Association of British HealthCare Industries both having already called for a postponement to the reforms.
It should be noted that currently the delay is just a proposal, and will first need to be approved by the European Parliament and Council in order to be effective. Given such approval is needed before the 26 May deadline, the Commission plan to use an accelerated co-decision procedure. However, until a formal postponement has been confirmed by the European Parliament and Council, businesses would be prudent not to ‘down tools’ in attempting to comply with the MD Regulation.
Areas not covered by the proposal
The proposal made the European Commission is not exhaustive, and consequently some areas of reform to EU medical regulation will go ahead unaffected, in particular:
- The European Commission have confirmed that, they are not proposing any deferral to the application of the EU In Vitro Diagnostics Regulation (“IV Regulation”). The IV Regulation, which supplements the MD Regulation will therefore become applicable as planned on 26 May 2022.
- Article 120 of the MD Regulation sets out a transitional ‘grace period’ running until 27 May 2024 during which certain medical devices may still rely on certificates issued under the Existing Regulations. It is not proposed that this grace period be extended.
The proposed delay pushes the application of the MD Regulation beyond the end of the Brexit transition period, meaning the MD Regulation will never be fully applicable in the UK. The Government had issued guidance indicating that The Medical Devices (Amendment etc.) (EU exit) Regulations 2019 will incorporate all key elements of the MD Regulation (and the IV Regulation), including the timetable being followed by the EU for its implementation - suggesting that a one year delay validly adopted by the EU Parliament/Council would be reflected in the UK. However, this guidance was revoked by the Government in February 2020, and so it remains to be seen whether the UK will follow the EU’s timeline, or whether a similar but distinct approach will be adopted.