We have previously written about the EU Medical Device Regulations (EU MDR) which came into force across the EU on 26 May 2021 – see here.
As these regulations were made during the Brexit transition period, the UK government previously confirmed that the EU MDR will not come into force in Great Britain. Instead, the old Medical Devices Regulation 2002 (as amended) will apply for now. That said, it is expected that there will be some changes to the UK’s regulatory framework for medical devices in the not so distant future. We consider the position in further detail below.
United Kingdom
The Medicines and Healthcare products Regulatory Agency (MHRA) is the designated authority that administers and enforces the law on medical devices in the UK.
The MHRA are currently holding a consultation on the future regulation of medical devices in the UK. The views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public are being sought before the consultation closes at 11.45pm on 25 November 2021.
The purpose of the consultation is to assist the UK government in developing a future regime for medical devices which enables:
- Improved patient and public safety
- Greater transparency of regulatory decision making and medical device information
- Close alignment with international best practice
- More flexible, responsive and proportionate regulation of medical devices
The consultation, which is available here, spans seventeen areas including classification of medical devices, clinical investigations/performance studies, post-market surveillance and vigilance, software as a medical device and environmental sustainability and public health impacts.
While for now, UK businesses should ensure that they are complying with the Medical Device Regulations 2002, they should be mindful that changes to medical device regulation are on the horizon. In the meantime, we will be keeping a close eye on the position as the consultation develops.
European Union
Finally, let’s briefly consider the future of the EU regulatory framework.
Pursuant to the EU MDR, medical devices must be classified as Class I, IIa, IIb or III according to risk. The lowest risk medical devices will be classified as Class I (for example, stethoscopes and wheelchairs) and the highest risk devices will be classified as Class III (for example, pace makers or heart valves).
On 4 October 2021, the European Commission’s Medical Devices Coordinating Group (MDCG) published new guidance aimed at helping manufacturers to classify their devices under the EU MDR before they are placed on the EU market. The guidance, which is intended to be practical, includes sections setting out how to carry out classification (with examples) and detailed explanations of individual rules for non-invasive devices, invasive devices and active devices. We suspect that this will be of great utility to manufacturers supplying devices to the EU market.
It should be noted that the guidance of the MDCG is not legally binding. That said, given the MDCG’s important role in the regulatory landscape, the new guidance is likely to be highly persuasive.
For the majority of businesses operating in both the UK and the EU, they will need to keep an eye on two regimes which already diverge and are likely to diverge even further in the future.
Elizabeth Pistak