Latest post-Brexit regulatory development in the UK on medical devices and in vitro diagnostic medical devices: UK government response to the future UK regulatory framework
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Practices: Life Sciences
On June 26, 2022, the Medicines and Healthcare products Regulatory Agency (the “MHRA”) published the government response (the “Response”) to the consultation on the future regulation of medical devices in the UK (the “Consultation”) , which occurred in late 2021, reported in a previous Alert.
The response highlights the two broad categories of changes proposed by the consultation:
- Regulations to improve patient safety and protect public health, by ensuring the quality of medical devices through regulatory oversight. These include the reclassification of certain products; strengthening post-marketing surveillance; and expanding the scope of the scheme to cover non-medical products (often cosmetics), which have a similar risk profile to medical devices.
- Regulations to increase innovation and access to medical devices. These include updates to the rules covering software and artificial intelligence as medical devices and the introduction of other routes to market, such as a route for “Innovative MedTech”, which would grant MHRA additional powers to authorize initial market approval.
The response recognizes the need for the UK to be seen as a favorable location for conducting medical device research, developing medical devices and manufacturing or supplying medical devices. Many of the proposed changes broadly bring the UK back into line with the EU regime, which was modified post-Brexit by the implementation of the EU Medical Devices Regulation (2017/745) and the Medical Devices Regulation. in vitro diagnostics (2017/746). Indeed, the response itself notes that the proposals bring the UK in line with international best practice in areas where the existing regime was deficient. In general, a divergence from the EU scheme is necessary for the protection of UK patients.
Respondents were generally supportive of the changes proposed by the consultation. When asked if the changes were proportionate, 67% said yes versus 17% said no, while 92% were positive about the level of ambition displayed. Thus, the response only suggests limited changes to the original proposals. However, there are some notable changes in approach. For example, in Chapter 11, the government decided not to change the scope with respect to implantable devices, considering that the products being considered for regulation were either already covered by the scope or there was no valid reason for them to be so covered. There was also very strong support from respondents in areas such as a globally harmonized device identification and coding system allowing unambiguous identification of devices in the UK market.
The Response endorses a phased transition to the new framework, which is expected to be adopted in 2023. Chapter 15 of the Response provides details on this point. Devices that are either UK certified or CE marked can remain on the market until their certificates expire or for a period of three to five years (depending on product type), whichever comes first. . This is provided so that the devices are not subject to significant changes in design or purpose, and that any post-market requirements applicable to the product under the new regulations are met. In addition, transitional provisions will apply to clinical investigations commencing before the entry into force of the new regulations, provided they comply with the new reporting requirements.
Finally, the response refers to two areas outside the scope of the consultation where we can anticipate future publication.
- The Independent Review of Fairness in Medical Devices, established to examine the extent and impact of possible ethnic and other unfair biases in the design and use of medical devices, is due to report by mid-2023. The MHRA has promised detailed advice on how manufacturers can address any issues that may arise from the review.
- Second, although the response discusses limited changes to the regulation of software and AI as a medical device, more detailed guidance, policies and standards are to follow, with the MHRA announcing a program of work on the subject. In addition, the UK government published a guidance document on 18 July 2022 setting out a pro-innovation approach to regulating AI, which will be the subject of a separate alert.