03 December 2021
FODO responds to future of medical device regulation in UK
Medical devices like spectacles, contact lenses and hearing aids must comply with medical device regulations. Therefore, these regulations affect all members, even if indirectly because of changes in the supply chain.
So, FODO has been working behind the scenes for many years with colleagues in Europe to get these regulations right for primary eye care. Our efforts had produced tangible results, ensuring EU medical device regulations would not pose unnecessary complexity and costs for primary eye care providers.
However, when we left the EU on 31 January 2020, existing EU-wide regulations no longer applied uniformly across the UK. Instead, the MHRA, the UK regulator for medicines and medical devices, has set its agenda for the future regulation of medical devices - a challenge regarding technology, as no one can predict its development.
MHRA has consulted on conformity assessments, unique device identifiers, distance sales, software (including AI), and post-market surveillance in anticipation of new rules in July 2023.
Our expertise on medical device regulations in Europe enabled FODO, working with ACLM and OSA, to take the lead in analysing these complex regulations and agree a sector-wide consensus.
FODO's view is that:
- The MHRA should regulate non-prescription contact lens
- Existing regulatory arrangements for medical devices used in primary eye care, such as spectacles (Class 1), prescribed contact lenses (Class IIa) and contact lens solutions (Class IIb), work well, and do not need to change
- We oppose over-regulation of these low-risk devices, which will add costs for patients and the NHS without increasing safety
- The new UK regulations will apply to manufacturers, importers, and distributors like the EU medical device regulations. However, they should not apply to frontline optical practices because this would be an unnecessary duplication without benefit, and it would be against the government's Better Regulation principles.
- A July 2023 implementation date is overly ambitious, and the new rules should be phased in starting with the highest risk devices.
You can read our response to the consultation, which ABDO and AOP also supported. As a sector, speaking with one voice, we help ensure primary eye care in the UK is heard.
Are you interested in learning more about our health policy work? Contact me at [email protected].