By Stewart Eisenhart, Emergo Group
A UK Department of Health review of how British regulators managed PiP defective breast implants has identified several regulatory improvements the Medicines and Healthcare Products Regulatory Agency (MHRA) should adopt to handle similar events in the future.
The report investigated how the MHRA and Department of Health handled the PiP issue, and recommended that the MHRA find ways to collect better evidence of medical device safety; expand its approach to examining reported problems with higher-risk devices; and improve its methods of communicating with the public.
Improvements to the broader European medical device regulatory scheme are also in order, according to the report, and healthcare providers must get better at reporting safety issues.
The Department of Health report precedes findings of a separate PiP review by the National Health Service of how cosmetic interventions are regulated in the UK. The European Parliament’s Environment and Public Health Committee has already issued measures to address future device safety issues in response to PiP implant safety issues occurring in the EU.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.