Medical device regulation consultation welcomed by product safety lawyers

The 10-week exercise to give people the opportunity to help secure better patient safety with a new regulatory framework has been announced by the Medicines and Healthcare products Regulatory Agency (MHRA).

The MHRA said the consultation would cover a broad range of regulatory issues, including how devices are assessed before being put on the market and post-market surveillance.

Leigh Day product safety lawyers have long been calling for urgent changes to the regulation of medical medicines and devices, most recently relating to the Allergan breast implants safety scare.

The MHRA’s slow response in the recall of PIP breast implants prompted criticism: it took 3.5 years to implement the Breast and Cosmetic Implant Registry (BCIR) in October 2016, following the recommendation being made in April 2013 in the Keogh report.

Most recently, in July 2021, the First Do No Harm report by Baroness Cumberlege made a recommendation that there would need to be substantial revision of the MHRA, particularly in relation to adverse event reporting and medical device regulation.

Reporting and monitoring of issues or adverse events associated with medical products is vital as it helps to identify and solve problems helping to prevent future issues occurring. Many people do not know that they can directly report a problem to the MHRA though the Yellow Card Scheme. The MHRA therefore does need to improve communication with the general public in order for it to be able to act as both as a source information and as an effective regulator.

Leigh Day product safety solicitor Zahra Nanji said:

“We are very pleased that the Medicines and Healthcare products Regulatory Agency have launched their long awaited consultation into medical device regulation. A change in the regulatory landscape in respect of medical device safety is long overdue.

“We are pleased to note that in the consultation the MHRA are asking for input regarding a number of historically problematic areas including: device classification, reporting systems, traceability and liability cover for adverse outcomes.

“The MHRA requires a root and branches overhaul. We hope that this consultation will be used as an opportunity to listen closely to stakeholders, act upon issues and concerns and do what is needed to reform itself to become an effective regulator which puts people and their safety at the centre of its work.”