Devices and desires: industry fights toughening of medical device regulation in Europe

“Kafkaesque” and “harmful to patients” are just two of the ways that new proposals to change the way medical devices are regulated in Europe have been described by industry organisations.

The planned reforms would create an “FDA-like system [that] would kill patients and kill innovative companies,” says Eucomed, the European medical technology trade association.1

But, as previous BMJ investigations have shown, the current system for allowing devices on to the market leaves patients across Europe vulnerable to poorly performing products.2 The system has led to a raft of headlines involving failed devices—including hip prostheses, intracranial stents, vaginal meshes, breast implants, and pacemakers.

Some of the 80 notified bodies—private organisations charged with evaluating the safety and reliability of devices—have been exposed as being more interested in attracting business than guarding the safety of patients. It’s those bodies that give companies a certificate to allow them to display a CE mark and sell throughout Europe.2

It’s a system that academics have described as “fragmented, privatised, and largely opaque; safety is dealt with in an unsatisfactory way and efficacy not at all.”3

And it would seem that many members of the European Parliament (MEPs) agree. On 25 September, a committee of MEPs on the environment, public health, and food safety committee of the European parliament agreed a series of changes that will see far more oversight and transparency than before with extra scrutiny for the highest risk devices.

Fifty two MEPs voted in favour, 12 against, with three abstentions. All of the ECR group—which includes the UK’s Conservative party—voted against.