The MHRA recently published an update on its plans to change the MedTech regulations. The update confirmed that the new framework will be introduced through four regulatory instruments to update and replace the UK Medical Devices Regulations 2002. The UK Government has confirmed that one regulatory instrument, which will set out new Rules for post-market surveillance (PMS), which strengthen requirements for vigilance and monitoring of products on the market, are expected to be tabled in Parliament before the end of 2024.

But the timing of the biggest changes, described as “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 expected to be in place by mid-2025. Given the delay, it is possible that this date will now be later.

After the PMS SI, the MHRA plans to consult later in 2024 on the content of the “Pre-Market SI”, but has stated that:

• The changes “will be consistent with” the 2021 consultation, the response to which was published in 2022. The 2021 consultation proposed:
  • Reclassification of devices similar to those contained in the EU MDR and EU In Vitro Diagnostic Regulations (EU IVDR);
  • Transitional provision for these products to allow, at a minimum, the products to be placed on the market until the certificate expires or for three years after the entry into force of the new regulations (in the case of general medical devices) or five years (in the case of IVDs);
  • Assignment of unique identifiers for certain medical devices, such as implantables; And
  • New requirements regarding claims made on devices by manufacturers.
• The 2024 consultation will include more detailed and targeted proposals on longer-term international recognition.
• Adopting a risk stratification approach for IVDs, adopting the International Medical Device Regulators Forum approach of an AD classification. Interestingly, the MHRA has indicated that most Class B devices will be able to self-assess their compliance with the regulations. Under the EU DRIV, only Class A IVDs can be self-assessed.

The MHRA has indicated that it aims to complete this consultation by the end of 2024. This timetable appears somewhat ambitious. As an example, the 2021 consultation lasted 10 weeks – so for the MHRA to achieve its ambition, the consultation will likely need to be published before the end of October 2024.

The implementation of pre-marketing IS is also unclear. Several steps must be completed before the regulations can be implemented, including notification to the World Trade Organization, which must publish the draft regulations for a period of at least 60 days for comment before the regulations can be implemented. tabled in the British Parliament.

The MedTech industry is closely following these changes.

On 10 October 2024, the Association of British Healthtech and CPI released the 2024 Pulse of the Sector survey report which highlighted the ongoing challenges of regulatory uncertainty in the UK market, with over 82% of healthcare players sector indicating that they have been affected in one way or another by the lack of clarity. Alongside regulatory uncertainty, the NHS Net Zero roadmap has also been cited as an unattractive factor for the sector. Despite these issues, the report remains optimistic as more than 30% of companies plan to expand R&D and manufacturing in the UK and many describe the UK as a research-friendly environment.