Director of devices to step down from the UK Medicines and Healthcare products Regulatory Agency

John Wilkinson to step down as director of devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in October.

During his seven years at the MHRA, Wilkinson has been involved in several initiatives such as establishing the agency’s position on medical apps and developing European Union regulations for devices and in vitro diagnostics.

The areas that Wilkinson focussed on were criticised prior to his arrival. At the time Wilkinson joined the MHRA in 2012, its response to the Poly Implant Prothèse (PIP) breast implant scandal was prominent in the media. A government report was published that exonerated the MHRA over the PIP scandal, however there was a call to, “take devices as seriously as medicines” in another published report.

The MHRA attempted to implement these regulations under Wilkinson’s appointment by actions such as working with the UK Foreign and Commonwealth Office in Brussels to push for regulations that would strengthen the oversight of medical devices across the EU and hiring clinical staff. The MHRA also attempted to improve the relationship it had with patients and the public.

Elaine Holmes, of the Scottish Mesh Survivors campaign group stated: "The agency is not an effective watchdog. It does not take our concerns seriously. We have written to it a number of times and telephoned it, but we get standard copy-and-paste replies. The agency does not listen to us.”

Additionally, Jackson Carlaw, a Scottish politician, during a parliamentary debate in 2016 stated: "I include the MHRA in my criticisms.

"When the public petitions committee took evidence from it, we learned that its detailed analysis amounted to three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000."

The MHRA has promised to take a "more structured approach to proactive patient engagement and improved safety messaging."

As Wilkinson plans to depart, large criticism remains about the MHRA’s handling of the adverse events linked to vaginal mesh devices.