Changes to European medical device regulations will not protect patients with diabetes and a central European Device Agency is needed, says EASD

The European Commission has just voted to approve new proposals to draft legislation to supposedly tighten medical device regulation and improve patient safety. But the European Association for the Study of Diabetes (EASD) says that the changes are inadequate and will not protect patients with diabetes.

EASD President Professor Andrew Boulton said: "These changes will do little to improve Europe's antiquated regulations for regulating devices, that were brought in for electric toothbrushes and stethoscopes - not the wide range of medical devices vital for diabetes patients today." He adds: "We are talking here about devices that people depend on for their lives, such as insulin pumps and technology that monitors blood glucose."

Professor Boulton made the comments during the annual meeting of the European Association for the Study of Diabetes, taking place in Barcelona, Spain. "Just as with drugs, devices can provide major benefits to patients but can also cause major harm when things go wrong," says Professor Boulton. Along with the European Society of Cardiology (ESC), EASD is calling for the European Commission to create a central European Device Agency (EDA), just as already exists for drugs (the European Medicines Agency/EMA). He was joined at the meeting by other experts in this field including Dr Deborah Cohen, Investigations Editor at the UK-basedBritish Medical Journal. Professor Boulton applauded Dr Cohen's reports and undercover work that have ruthlessly exposed Europe's sub-standard system for regulating medical devices.

The system for approving medical devices in Europe is far less rigorous than that required for approving new drugs, and is also less stringent than the system used to approve devices in the USA. To obtain approval for a medical device in Europe, manufacturers must be given the Conformité Européenne (CE) mark, awarded by so-called "Notified Bodies" (NB), which are generally private organisations under the auspices of the 'competent authority' (regulator) of the European Union member state in which they are based. To register a device such as a new blood glucose monitor, a manufacturer can choose any NB in any country, to which it will pay a fee.

The NB is then meant to ensure that the device meets the required specifications. Once the device has gone through this process, it will receive a certificate for a CE mark, and can be marketed across Europe.

However, Dr Cohen's various investigations have, along with other media reports, shown that this system can be subject to 'notified body shopping' in which companies can look for the NB most likely to approve their device, as well as receiving inappropriate advice from NBs about how to get their device through the regulation process and onto the market. She was, along with a major UK newspaper, able to get a completely fictional device through most stages of the approval process with completely fabricated data.

The changes mainly focus on class III (highly complex, mostly implantable) devices. Diabetes pumps are in class II, and indeed all diabetes devices fall into either class I or II, and thus are not affected. These revised proposals by the European Commission, that must still go through a final round of voting in October, are rumoured to have been watered down after intense lobbying by member states and industry. It is understood that proposals for a central EDA, the preferred option of EASD and ESC, have been dismissed by member states. Other proposed changes include:

• EMA will designate "Special notified bodies" for class III (extended to implantable + devices incorporating/dispensing/removing medicines)
• Stricter requirements on qualifications and training for "Special notified bodies"
• Network of "Special notified bodies" to exchange good practice + ensure convergence in work Manufacturers of devices in class III extended will select a "Special notified bodies" to conduct the conformity assessment of product
• But in some listed cases (novelty of the device, public health concern, etc.):
• A new Assessment Committee for Medical Devices (ACMD) - may decide to conduct a case-by-case assessment of the clinical data and of the post-market clinical follow-up plan. ACMD will be sub-divided into 21 sub-groups and composed of medical specialists nominated by Member States + 3 patients' representatives + 1 EMA representative. The Opinion of the Committee will finally be sent for adoption through comitology + be binding for "Special notified bodies"

Final voting on the draft legislation is likely to take place at the end of October.

"Diabetes care has progressed massively thanks in many ways to improved device technology, but the regulation has not kept up with these advances," concludes Professor Boulton. "We desperately need a system in place that protects diabetes patients from potential harm. Or must we wait for another major device scandal before the European authorities take the appropriate action?"

Dr Cohen adds: "These changes are the bare minimum required to really ensure the safety and effectiveness of medical devices and protect patients. It leaves patients across Europe in a position where some are more protected than others. It's unclear how these new regulations will impact on the devices involved in diabetes or other class II devices, though it appears to be good news for those with most complex, highest risk devices, such as hips and other implants. I hope that the current proposals are not watered down further by lobbying."