The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood transfusions in the UK. Since February 2012, its director of devices has been John Wilkinson, who recently announced that he will be leaving the organisation at the end of October 2019.
Wilkinson has made a significant impact on medical device legislation across the UK and the EU, and attempted to foster a culture of change at MHRA, listing the strong team he has built at the organisation as one of his biggest achievements. His impact on the medical devices industry over the past seven years is undeniable, even as he leaves the organisation against a backdrop of criticism.
Wilkinson joins MHRA during toxic PIPs scandal
Wilkinson joined the MHRA in February 2012 at the height of the fallout from the Poly Implants Prothèse (PIP) breast implant scandal, following 18 months during which his position as director of medical devices had been left vacant.
The now-infamous French breast implant manufacturer PIP had been making the devices with cheap, unapproved silicone designed for use in mattresses rather than the human body. These implants were two to six times more likely to rupture than approved implants, which themselves have been estimated to rupture around 10% of the time.
Wilkinson says: “Although it was a baptism of fire, I think it concentrated a lot of minds on what we needed to do to improve the system which will continue to need to evolve in the face of massive changes in technology and societal attitudes to risk.”
In December 2013, PIP president Jean-Claude Mas was sent to prison for four years and fined €75,000 after being convicted of fraud.
Developing the CAMD network
The Competent Authorities for Medical Devices (CAMD) network was established to enhance collaborative working, market surveillance and communication around medical devices across Europe. The network was set up following the PIP scandal, when European commissioner John Dalli called for immediate action among member states to ensure safeguarding around medical devices.
Wilkinson was chair of the CAMD Executive Group for two terms, and since then has represented the MHRA on the executive board. He has supported CAMD in enhancing the collaboration between EU member states and the European Commission with regards to the medical devices regulatory system.
CAMD has been responsible for the establishment of an implementation taskforce for the new EU Regulations for Medical Devices (MDR) and in vitro Diagnostic Medical Devices (IVDR). It has facilitated collaboration and cooperation among the medical device sector as these new regulations came into place.
The organisation aims to implement effective, robust regulation across the EU and ensure the best possible protection of medical device-adjacent public health across the continent.
Refining MHRA’s position on medical apps
In August 2016, the MHRA issued official guidance from Wilkinson and his team on which healthcare apps could be considered as medical devices, and therefore needed to comply with regulatory guidelines to be accepted as safe.
Apps that gather data from a person or a diagnostic device and then analyse the data to make a diagnosis, prescribe a medicine or recommend treatment are now classed as medical devices.
Examples include blood glucose monitors that register their results on a mobile app rather than a dedicated handheld device, or electrocardiogram (ECG) apps to help the user track their heartbeat. While dieting apps process data from human beings in a similar way, these are not classed as medical devices – they may encourage a healthy lifestyle but they’re not made for the explicit treatment of a disease.
Software developers are now able to use the guidance to identify if their product would be classed as a medical device and need to go through the requisite regulatory testing. It has also empowered consumers to know when to report safety or performance issues involving medical apps to the MHRA’s Yellow Card Scheme, which exists to collect and monitor information on suspected adverse incidents with medical devices.
Transvaginal mesh scandal
As Wilkinson leaves the MHRA, he does so under a cloud of criticism. The regulator has been heavily criticised for its handling of the now-infamous vaginal mesh scandal.
Transvaginal mesh implants surgically fitted in thousands of women across a timespan of decades were found to be negligently designed, leading to complications such as incontinence and chronic pain, with some deaths even being linked to the devices.
The MHRA has faced strong criticism for its handling of the case, after Member of Scottish Parliament Jackson Carlaw revealed that the agency’s screening procedure for the implants amounted to “three postgraduate students doing a desktop exercise for two weeks at a cost of £20,000”.
Despite claims to the contrary, Wilkinson maintains that the outcomes of the scandal have had no bearing on his decision to retire.