Certification bodies that authorise the use of invasive medical devices would be subject to stronger EU scrutiny under a proposal to be adopted by the European Commission on Wednesday (26 September).
The Commission will not, however, propose centralised EU authorisation of medical devices, as called for by some campaigners and MEPs following the Poly Implant Prothèse (PIP) breast-implant controversy in France earlier this year. PIP is alleged to have used an industrial-grade silicone instead of medical silicone in the implants, making them prone to rupture. The implants were approved by a private German certification body.
Under current rules, dating from 1990, medical devices such as implants and pacemakers are given pre-market authorisation by independent certification bodies approved by member states. These may be either private or public.
Following the scandal, there were calls for this system to be scrapped and for the EU to have a central authorisation body as in the United States, which has the Food and Drug Administration (FDA). “It is time, for those medical devices which pose the greatest risks to our health, to implement a marketing authorisation at the European level,” said Françoise Grossetête, a French centre-right MEP.
But Eucomed, the European medical-technology industry association, said that such a system would lead to delays to patients getting urgently needed medical devices and would not improve safety.
The revision of the medical-devices directive, which had been planned for this year anyway, will not overhaul the existing system but instead establish a centralised oversight system to ensure the certification bodies are operating appropriately.
Eucomed welcomed the decision not to have a centralised system. “We expect to agree with the majority of the Commission's suggestions,” said spokesman Ingmar de Gooijer. “All along, the industry has made it crystal-clear that we do not want an incident like the PIP breast implants to happen again, and we believe that the current European system needs to be changed.” However, he added that Eucomed still has concerns over the proposed scrutiny procedure and its possible effect on speed of access and innovation.
“We must not forget that the European system has been very good for patients,” he added. “It has a high safety profile – as high as the American FDA system – and ensures that patients do not need to wait longer than necessary to receive life-saving medical technology. American patients need to wait on average two years longer than European patients.”