European Medical Device Regulations Update

Following the publication of a proposed replacement to Europe’s medical device regulations in late 2012, a number of industry groups have sharply criticised the proposal’s way of handling new high risk devices—the Scrutiny Procedure. The most vocal group opposing this is Europe’s association of medical device industries, Eucomed.

Since the proposal was published Eucomed have released several campaigns in an attempt to drum up support for opposition to the Scrutiny Procedure. Eucomed’s criticism is that the procedure is over the top, and will stifle innovation. They say that with the scrutiny procedure in place, the quality of care in Europe is at risk and that Europe’s currently dynamic and responsive healthcare industry, admired by many in the world, will slow down where the release of new innovative life-saving devices are concerned.

Having asked various observers in the medical device manufacturing industry, Medical Plastics News understands that Eucomed’s views are widely supported.

Eucomed’s most recent campaign is called Don’t Lose the 3. The 3 refers to what Eucomed describe as a three-year advantage regarding when devices become available—saying they’re available in Europe three years before markets elsewhere in the world. An example which demonstrates this, a landmark invention, is Abbott’s landmark fully resorbable Absorb stent, which was launched in Europe in 2012 but has only just begun clinical trials in the USA. It is Medical Plastics News understanding that much of the work in developing and manufacturing the Absorb stent was done in Europe, notably Ireland.

Image: Eucomed hopes that its Don’t Lose the 3 Campaign will persuade Europeans to register opposition with their MEPs over the proposed Scrutiny Procedure for approval of high risk devices under the proposed European medical device regulations.

Eucomed’s statement on the thinking behind the campaign is as follows. “Today in Europe, people have access to life-saving medical devices three to five years sooner than other parts of the world. The reason for this is Europe’s unique decentralised device-specific approval system, which has proven to be as safe as other systems in the world and is saving and enhancing many lives every day.”

“However, some voices in Brussels want to radically change the system causing us to lose our three-year advantage. What’s worse is that research shows that these radical changes will not make the system safer for patients.”

“Many groups and experts in Europe, including doctors, patients and industry, agree that the current European system needs to be improved to cope with new medical technologies and innovations. But let’s keep what works and fix what needs to be improved instead of radically changing the system.”

Ingmar De Gooijer, Eucomed’s director of communications said: “When asked what I think is best for European patients and industry: keep the decentralised approval system and fix what needs to be improved instead of radically changing what we have today into something that won’t guarantee more safety.”

He added: “I believe that Europeans, including myself, want a safer system that doesn’t cause unnecessary delays in innovative medical technologies reaching us because they improve and save our lives. And when you take the time to look at how we can reach the desired outcome of improved safety and timely access, you realise that it can be achieved together through significantly improving what we have today.”

Comparing the current European device approvals system with that of the USA, Ingmar added: “When speaking to American journalists who cover the global medical device industry, I usually get the same response: they are astonished by the direction in which Europe is going. They do not understand why Europe wants to move towards a US-system of approving medical devices that has resulted in Americans waiting several years longer than Europeans for innovative medical technologies without any safety benefits.”

Ingmar notes that the FDA has recently requested an 11% budget increase to speed up the approval times in its centralised pre-marketing authorisation process.

On April 19, 2013, Eucomed also noted measures proposed by German member of European Parliament (MEP) Ms Roth-Behrendt in her draft report on medical devices for the Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament.

Ms Roth-Behrendt is calling for a shift towards a centralised pre-market authorisation system, which if carried through to the final legal text will confront patients in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety. Following publication of the MEP’s report, Eucomed said it was a step backward for patients, healthcare systems and for Europe.

Eucomed go on to say that the measure would also lead to the creation of a new enormous bureaucratic system with no benefits.

The position of Ms Roth-Behrendt will be taken forward for discussions with her Parliamentary colleagues of the Environment, Public Health and Food Safety (ENVI) committee. Members of the ENVI Committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the European Parliament.

To register your support for Eucomed’s Don’t Lose the 3 campaign, Eucomed are asking readers to write to their MEPs to ask them to join the campaign. Visit the Don't Lose the 3 website to learn more.