Overview
The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices Regulations 2002. The UK government has confirmed that a statutory instrument, which will set out new rules for Post Market Surveillance (PMS) which will strengthen requirements for vigilance and surveillance of products on the market is expected to be laid in Parliament before the end of 2024.
But the timing for most important changes, described as the “core regulations” or “Pre-Market SI”, and which will include the bulk of updates to the UK MDR is still unclear. According to the MHRA RoadMap published in January 2024, these core regulations were intended to be laid in mid-2025. Given the delay, it is possible that this date may now be later.
After the PMS SI, the MHRA plans to consult later in 2024 about the content of the “Pre-Market SI” but has said that:
- The changes “will be in line with” the 2021 consultation, the response to which was published in 2022. The 2021 consultation proposed:
- Up-classing of devices similar to those contained in the EU MDR and EU in vitro diagnostic regulations (EU IVDR);
- Transitional arrangement for these products to allow, at a minimum, products to be placed on the market until either the certificate expires or for three years after the new regulations take effect (in the case of general medical devices) or five years (in the case of IVDs);
- Assignment of unique device identifiers for certain medical devices, such as implantables; and
- New requirements about the claims made about devices by manufacturers.
- The 2024 consultation will include more detailed and focused proposals about longer term international recognition.
- The adoption of a risk stratification approach for IVDs, adopting the International Medical Device Regulators Forum approach of an A-D classification. Of interest, is that the MHRA has indicated that most class B devices will be able to self-assess conformity with the regulations. Under the EU IVDR, only class A IVDs may be self-assessed.
The MHRA has said that its ambition is to complete this consultation by the end of 2024. This timetable appears somewhat ambitious. By way of example, the 2021 consultation was 10 weeks long – so, for the MHRA to meet its ambition, the consultation will likely need to be published before the end of October 2024.
The implementation of the Pre-Market SI is also unclear. There are several steps which need to happen before the regulations can be implemented, including notification of the World Trade Organisation, which must publish the draft regulations for a period of at least 60 days for comment before the regulations can be laid in the UK Parliament.
The MedTech industry is closely monitoring these changes.
On 10 October 2024 the Association of British Healthtech and CPI published the 2024 Pulse of the Sector Survey Report which highlighted the continuing challenges about regulatory uncertainty in the UK market with more than 82% of the industry indicating that they had been affected in some way by the lack of clarity. Alongside regulatory uncertainty, the NHS Net Zero Roadmap was also raised as an unattractive factor for the sector. Despite these issues, the report still indicated optimism with over 30% of companies planning to expand R&D and manufacturing in the UK and many describing the UK as a research-friendly environment.
