Medical products from plasters to pacemakers across the EU will be subject to tougher scrutiny before their launch and surveillance after they reach the market, following the discovery of faulty breast implants earlier this year.
Under European Commission plans unveiled on Wednesday, standards will be raised for national “notified bodies” to ensure consistent quality controls and greater evidence of safety, with companies required to provide unique identification numbers allowing any faulty products in future to be traced and recalled.
The proposals, announced by John Dalli, the EU Health and Consumer Policy Commissioner, follow growing criticism of Europe’s regulatory system over the debacle of faulty breast implants, which were manufactured by PIP of France, and other safety scares including problems with ASR metal-on-metal artificial hips.
They aim to address concerns while limiting the costs to Europe’s 25,000 medical device companies, which are estimated to generate nearly €100bn in annual sales, employ 500,000 staff, invest substantially in innovation and provide more rapid access to patients than the US.
Mr Dalli, who has already urged tougher unannounced inspections of manufacturers under existing rules following the PIP scandal, said: “The proposals adopted today significantly tighten the controls so as to ensure that only safe devices are placed on the European Union’s market.”
His plan was broadly welcomed, although industry cautioned over the greater uncertainties and costs of a proposed extra level of EU scrutiny on top of national authorisations, while BEUC, the European Consumer Organisation, argued it did not go far enough in “increasing quality and safety standards”.
The plans call for national regulators in future to tighten the commercial “notified bodies” operating across Europe that inspect device companies to tackle the current variations identified in “quality and depth” of their review. Greater information on the full range of approved devices would be made public across the EU.
The definition of medical devices would be updated to include products including aesthetic implants and in vitro diagnostics, and scientists would become more involved in discussions over approvals to higher levels of clinical evidence.
Officials concluded that reform of the current device system was required, but held back from a more radical overhaul that would have replaced the CE quality mark with a more formal marketing authorisation similar to that used for pharmaceuticals. Their aim is to adopt the modifications by 2014, with implementation by 2019.
They estimated the annual cost to companies of new tracking numbers on products of €22m would be more than covered by existing varied registration requirements in EU member states, but there would be up to €12.5m in costs for centralised monitoring of the new regulatory system with the hiring of up to 50 new staff.
Serge Bernasconi, chief executive of Eucomed, said: “It’s critical we have a system that is accepted, recognised and respected. But the scrutiny system might result in patients waiting longer for life saving technology, without increasing safety and while hampering innovation.”