Over the last few days there has been a lot of coverage in the media – including Panorama on BBC1 on Monday 26 November – about how medical devices are poorly regulated and the danger they pose to patients.
This story is being pursued by journalists in a large number of media outlets across the world.
Although many of the stories simply reference medical devices, in fact the focus of concern is implantable devices – such as hips, pacemakers, vaginal mesh.
The reports raise concerns that medical devices (unlike medicines) are poorly regulated, there is no common or gold standard, one notified body in a member state can grant a CE mark for a medical device which may be of a poor standard, and industry bodies have too much sway over the regulatory framework.
Rules making it tougher for devices to get approval are due to be introduced in Europe in 2020, under the new Medical Devices Regulation (MDR). The MHRA – the regulator for medicines and medical devices in the UK – has played a leading role in developing the new MDR. It has recently consulted industry on proposals to ensure effective regulation post Brexit.
Commenting on the story, Ann Blackmore, Director of Policy and Strategy at FODO, said:
“Medical devices used in the optical sector are classified as low risk. However we do of course want there to be an effective and proportionate regulatory regime for such devices. We have been working and will continue to work with manufacturers and regulators to that end.”