Flaws in EU regulation of medical devices, says BMJ
24 October 2012
A joint undercover investigation by the BMJ and the
Daily Telegraph has exposed flaws in the EU system used to
grant market access for devices such as replacement hips, cardiac
defibrillators, and breast implants.
The investigation involved submitting a fake application for a
large diameter metal-on-metal total hip prosthesis for approval by a
notified body in Slovakia—the commercial organisations charged with
evaluating the safety and performance of medical devices across
Europe by granting them a CE certificate.
The hip — whose specification was designed for the purposes of
the investigation — had similar specifications to the DePuy ASR XL
acetabular system — a device that has been recalled from the market
after failing at unacceptable rates and releasing metal ions into
patients’ blood. Nevertheless, last week the notified body
provisionally allowed the product to go forward to certification.
One notified body authorised to certify products for medical use
across Europe, has been secretly recorded admitting that it is “on
the side of the manufacturer”.
ITC, a regulatory organisation in the Czech Republic was also
prepared to consider licensing the product, despite widespread
concerns about the use of large diameter metal-on-metal hip
prostheses. In some countries, surgeons have been told not to use
One representative of ITC told reporters that his company would
not put “obstacles” in the way of approving the device and said it
was “on the side of the manufacturer and their products, not on the
side of the patients”. Another notified body was recorded admitting
that some of the dossiers for products legally on sale were
“horrible” because of the deficiencies of the regulatory system. The
ITC did not respond directly to any points later raised but said it
complied “in full accordance with the law.”
The investigation raises serious questions over the safeguards
protecting patients. The system of licensing medical devices and
surgical implants works on a pan-European basis and regulators in
this country refuse to disclose where products have been certified.
More than 70 private agencies are competing for business —
meaning the system is susceptible to corrupt practices, such as
those uncovered during the recent PIP breast implant scandal.
The regulatory system works in a similar way to the licensing
process for household electrical appliances and toys rather than the
far more rigorous system applied to approving drugs.
Medical experts last night condemned the regulators and demanded
an urgent review to protect patients from another “inevitable”
scandal in the wake of the problems surrounding PIP breast implants
earlier this year.
Dr Carl Heneghan, a medical expert at Oxford University, who
provided advice on the BMJ / Daily Telegraph investigation, said
last night: “To put it bluntly device regulation is in disarray: the
evidence requirements at the time of approval are woeful, the
conduct of notified bodies is substandard, and individuals
supposedly representing the regulatory system are conflicted and in
many cases under qualified.
“This all means that the system now heavily favours manufacturers
at the expense of patient safety.”