Europe split over new rules on medical devices

Following the widely-publicised PiP breast implant and metal-on-metal hip replacement scandals, EU health representatives are considering the introduction of two new pieces of legislation on the approval of medical devices.

However, at a meeting last week, while speakers from all groups agreed with the need to beef up patient safety with improved checks and changes to the system of Notified Bodies whose job it is to review and approve products in each of the EU member companies, they could not come to a consensus on whether to insist devices should have EU pre-market authorisation.

Speaking at a meeting on the subject, German representative, Rapporteur Dagmar Roth-Behrendt, said definitions for single-use devices would have to be ‘made clearer’ as well as conditions and liabilities for reprocessing them. She also proposed to set up a more transparent fee system and to ensure that notified bodies have their in in-house expertise. She also spoke in favour of a centralised pre-market authorisation process for certain devices.

Her comments come after the high-profile cases involving metal-on-metal hip replacement implants and the PiP breast implant scandal. In the case of the hip implants, thousands of UK patients were given the devices, which were later found to poison the body, with failure rates of up to 50% in some cases. The PiP implants were found to have been made from industrial silicone instead of approved medical-grade materials, with the manufacturer altering the formula since the original regulatory approval was given.

Creating a system that causes unnecessary delays in products coming into the market will harm patients by limiting access to new treatments

The planned rewrite is the first time the regulations have been updated since the directives were first passed during the 1990s. The original rules, written to protect the commercial interests of manufacturers, meant that all clinical evidence gathered in the development and testing of medical devices, and the details of adverse reactions linked to them, could be kept behind closed doors.

The improvements, it is hoped, will help to strike a fairer balance between encouraging the continued development of new medical technologies and enabling clinicians and patients to make more informed choices by introducing rules similar to those that already apply to the pharmaceutical market, where manufacturers have to make data from clinical trials public after drugs are licensed.

During the EU debate, members called for improvements to the current system for approving devices via Notified Bodies, which are independent third-party organisations whose job it is to award CE mark approval and to carry out a conformity assessment for medium and high-risk equipment. In the wake of the PiP scandal, the spotlight fell on these organisations, with criticism that they were operating to different standards across Europe and that their decisions and actions were not being properly scrutinised.

Irish MEP, Mairead McGuinness, said many Notified Bodies did not have the competence, expertise or the resources to scrutinise products in more detail and called for the panels to be strengthened ‘in order to make sure we have experts in place’.

And Germany’s Holger Krahmer added: “It is essential to avoid competition between notified bodies as companies look for who is the cheapest.”

On the issue of pre-market authorisation, he said: “Every centralised decision we take has to be thought about twice.” But he spoke in favour of ‘increasing the quality’ of Notified Bodies.

There was also calls for improvements to tracking and traceability to avoid a repeat of the PiP scandal where it was not immediately known how many women were affected and where they could be located.

We need to make sure inspections are being carried out without being requested and that products are traceable

European Conservatives and Reformists Group member, Denmark’s Anna Rosbach, speaking on behalf of UK party colleague, Marina Yannakoudakis, said: "We need to make sure inspections are being carried out without being requested and that products are traceable". On the issue of reprocessing, she added: “It is very important that responsibility and liability are clearly defined, and this is rather missing from the EC proposal.”

Changes to the rules are being supported by industry. Mike Kreuzer, executive director of technical and regulatory affairs for the trade body, the Association for British Healthcare Industries (ABHI), said: “The medical device industry has long called for the overhaul of the medical device directives. Recently a number of high-profile events have shaken public confidence in the system and it is crucial that both industry and policymakers begin rebuilding this trust by improving the system and ensuring that issues such as the PiP scandal never happen again.”

But he warned: “At the same time as tightening up the system and improving issues such as transparency and vigilance, policymakers must also make sure that patients are able to access innovative new treatments at the appropriate time. Creating a system that causes unnecessary delays in products coming into the market will harm patients by limiting access to new treatments.”

The new EU legislation will go to a vote in June.