New Medical Device Regulations Reach The Final Stage Of Negotiation

Specialist Lawyers Call For Safety Improvements To ‘Flawed System’


The European Council of Ministers has confirmed that the final stage of discussion on new regulations governing medical and in vitro devices should commence shortly, with specialist lawyers urging that it must lead to safety improvements.

Talks between the Council of Ministers, the European Commission and the European Parliament have been given a mandate to proceed and it is hoped the talks should lead to finalisation of the regulations.

In a statement, the Council of Ministers confirmed that the regulations will be aimed at strengthening the rules on placing medical devices on the market and tightening surveillance after approval.

The proposals will require manufacturers to plan, conduct and document a clinical evaluation of medical devices prior to receiving marketing approval. Manufacturers will also have to plan post market surveillance systems with the aim of identifying any faults with the product following approval.

The proposals follow a number of recent high profile medical device scandals, such as Poly-Implant Prosthese breast implants and the metal on metal hip prostheses, which have been widely acknowledged to be harmful, in spite of having CE Mark approval.

Specialist product liability experts at Irwin Mitchell, who represent many consumers adversely affected by defective devices, have called for the amended regulations to reduce the number of dangerous products which reach the market and also lead to quick identification of others.

Expert Opinion
“We have long-held concerns regarding the existing EU framework for medical device regulation, which has been subject to a great deal of criticism in recent years for its lack of rigour. Most commentators agree that reform is long overdue.

“Under the current system, any product – including a medical device - can be marketed and sold in the EU following the grant of a CE mark. CE marks are granted by ‘notified bodies’, which are individual commercial enterprises paid by manufacturers to deal with the CE marking process. Many notified bodies also offer consulting and marketing services for the same manufacturers.

“One of our concerns is that there is a fundamental conflict of interest for these notified bodies. Manufacturers want to get their products to market as quickly and cheaply as possible, and so the best way for a notified body to turn a profit is to develop a reputation for providing quick and easy approvals.

“It is our belief that the system doesn’t encourage rigorous and effective regulation and while it isn’t yet clear what difference the proposed reforms will make, the suggestion of a greater emphasis on clinical trials and post market surveillance is clearly a step in the right direction for patient safety.”
Matthew Newbould, Solicitor

The CE mark system has been under the spotlight in two undercover investigations in recent years.
The first,  conducted by the BMJ and the Telegraph in 2012, involved applications for CE marking to 14 notified bodies for the fictional 'Changi' metal on metal hip.
The hip was described as ‘substantially equivalent’ to three existing metal on metal hip models known to have unacceptably high failure rates. Two had been withdrawn from use and the third was subject to legal action.

The application dossier contained data which showed that the prosthesis would wear at a catastrophic rate after implantation, leading to cobalt and chromium levels that would constitute a threat to general health; and that the prosthesis would be likely to deform and fall out. In spite of that, six of the notified bodies returned firm quotes for approval and none rejected the application outright.

More recently, an Oxford scientist, Professor Carl Heneghan released footage of representatives of one notified body, TUV, confirming that there should be ‘no problem’ in obtaining a CE mark for surgical use of another fictional product, ‘mandarin mesh’, which was in fact the netting normally used to hold supermarket oranges.

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