The European Union process of assessing whether medical devices are fit for public use are “inconsistent and opaque”, researchers have claimed.

Notified bodies give products the CE mark seal of approval within the European Union, but the PIP breast implant scandal shows that the process cannot guarantee “safe and effective” patient care, according to a research group led by Edmund Neugebauer at Herdecke University in Germany.

The team said that Europe needs “a central, transparent, and evidence-based regulation process for devices”, which can range from bandages to life support machines.

“Poly Implant Prothese breast implants show that the process cannot guarantee safe and effective patient care,” the authors wrote in the BMJ.

“The certification process is inconsistent, opaque, and operates in the interests of manufacturers. It requires insufficient evidence of efficacy of the devices and no long-term follow-up of patients.”

Last year, John Howlett, head of the British Standards Institute, raised concerns that if a product is denied by one notified body, some manufacturers seek approval from another and pass the test of standard.

The authors of the latest report said the regulation process should be centralised.

They wrote: “Under the proposed legislation manufacturers of devices will still be free to choose to which of the 84 notified bodies they submit their application.

“We believe that approval of high and medium-risk devices … should be done by a new public body similar to the European Medicines Agency or that the EMA is given an extended mandate to carry out these assessments.”

They also called for better transparency about the approval process.

“Currently, there is no publicly available summary describing the basis for granting a CE mark,” they wrote.

“Members of the public therefore cannot find out information about the process (place of application, requirements for application, pre-defined criteria for decisions) or the rationale for an approval (efficacy and safety data). We called for this information to be available on a publicly accessible website for all approved devices, irrespective of risk class.”

Around 47,000 British women are believed to have been given implants manufactured by French company Poly Implant Prothese. They were filled with non-medical grade silicone intended for use in mattresses and have been linked to rupture and swelling in the body.

 

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