LONDON There is no need for radical reform of Europe's medical device regulation system in the wake of a scandal over French PIP breast implants, Britain's medical regulator said on Thursday, but some improvements should be made to the current system.
Kent Woods, the head of Britain's Medicines and Healthcare products Regulatory Agency (MHRA) said no regulation system can guarantee against a case like that of Poly Implant Prothese (PIP), which he said was "manufacturing fraud," and rejected suggestions that Europe's system needs a dramatic overhaul.
Critics say Europe's weak regulation of medical devices is partly to blame for allowing PIP to manufacture substandard silicone breast implants for up to a decade, and be used by hundreds of thousands of women around the world.
Woods said the PIP case was a rare and unusual one and should not prompt a knee-jerk reaction. Instead he called for better surveillance and reporting of any problems with medical devices on the market, and more coordination between national medical regulators in the EU's 27 member states.
"The question that arises is whether the broad principle of how we do it in Europe is right or not?," he told a briefing in London. "Are we looking for incremental improvements to a system that is in place, or are we looking for root and branch change?"
There was "very strong support" among regulatory authorities in Europe and at the European Commission, he said, that root and branch change "is not what is required."
The European Union's health and consumer affairs commissioner John Dalli said last week that EU governments should strengthen safety controls on high-risk medical devices by using spot checks on products and manufacturing facilities.
France's health authorities have also called for tighter controls after a near two-year investigation into PIP, which has now gone out of business. [ID:nL5E8D13N7]. They said EU laws relating to medical devices "must be radically redrafted."
The European Commission is drawing up proposals for reforming regulation of devices, including measures for more pre-market testing and post-marketing surveillance, which will go before EU ministers later this year.
More than 500,000 medical devices are sold in the EU, ranging from bandages, dentures and wheelchairs to pacemakers and implants. They are regulated under the Conformite Europeenne, or "CE mark," system, which is also used for gadgets like toasters or coffee machines and for children's toys and mobile phones.
Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.
Getting a CE mark is tougher for devices like pacemakers or implants than for toys or toasters, but it can still be gained with relatively few tests - certainly less scrutiny than the extensive clinical trials required for pharmaceuticals.
The system is built on around 80 Notified Bodies, mainly private companies scattered across Europe's 27 member states, who are authorized to give a CE mark to a product once they are happy it has met certain safety and performance requirements.
Peter Wilmshurst, a consultant cardiologist at Shrewsbury and Telford Health Authority, who also spoke at Thursday's briefing, was highly critical of the European system which he said encouraged medical device makers to "shop around" to find a Notified Body most likely to give them "the easiest ride."
"The Notified Bodies are not working for patients, or for the European Union, they are working for the companies (who make the devices)," he said. "Therefore they have an incentive to get products through because if they're seen to be an obstructive Notified Body, then they may not get work in the future."
Wilmshurst said he'd like to see Europe's system changed completely so medical devices were regulated by a single central and accountable body like the Food and Drug Administration, which regulates devices and medicines in the United States.
(Reporting by Kate Kelland; Editing by Andrew Callus)
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