OSA responds to MHRA consultation

OSA responds to MHRA consultation

The OSA has this week responded to the medical regulator’s consultation on the future regulation of medical devices in the UK. We have also followed up the response with a letter to the MHRA summarising our concerns and priorities.

Our response sets out four principles which should underpin the regulation of medical devices:

1. Ensuring patient safety.
2. Regulation that is proportionate to the risk each device poses.
3. A system that is workable for manufacturers, economic operators and the MHRA itself.
4. A regulatory system that aligns as closely as possible to systems operating elsewhere to reduce the likelihood of needing to comply with dual (or even multiple) regulatory systems.

We have argued that many of the proposals outlined in the consultation should not apply to low risk, high volume devices. They would not be proportionate to the low level of risk such devices pose, would add nothing to patient safety, and would impose an undue regulatory and bureaucratic burden on manufacturers and economic operators. This would be the case for example with proposals for UDI, and the requirement for financial coverage to compensate patients.

We are also concerned that the consultation makes a number of proposals which could open the MHRA to accusations of regulatory creep, by extending the role of the regulator to matters that are properly matters for a business itself – for example having access to necessary legal and regulatory advice.

The consultation also makes proposals on environmental sustainability. The OSA strongly supports the need for everyone, including the manufacturers and distributors of medical devices, to consider their environmental impact and take steps to mitigate that impact. However, we do not believe that this should be included in medical device regulations. Widening the scope of the regulations to incorporate matters which are not clinical and do not add to patient safety would be inappropriate and could be confusing. There are a other regulatory regimes which more properly encourage or require manufacturers to address their environmental impact.

This is just the first step towards creating the new UK regulatory system. The OSA will continue to work with the MHRA, to represent the interests of the UK optical industry, as detailed proposals and draft regulations emerge.