This article is part of our special report Medical devices regulation.
The European Parliament and the Commission are at odds over proposals to create a US-inspired centralised approval system for medical devices, which supporters say would improve patient safety.
The EU's new legislation on medical devices was debated in Parliament during a workshop hosted by the Socialists and Democrats (S&D) group on Tuesday (19 March).
Dagmar Roth-Behrendt, a German MEP who is in charge of steering the legislation through Parliament, said she will propose a centralised approval system to make medical devices safer for patients.
Following the 2012 health scandal involving breast implants manufactured by the now-defunct French company Poly Implant Prothèse, the European Commission has proposed a system where countries mutually recognise decisions taken by national bodies but stopped short of proposing a centralised approval system.
Under the Commission proposal, national bodies would be responsible for approvals but would be able to review, scrutinise and comment on assessments performed by others.
In the United States, the Food and Drug Administration has a pre-market approval (PMA) process for so-called 'Class III' devices that represent the highest risk to public health, or "novel technologies".
Roth-Behrendt has previously stated that she would like to see the US system introduced in the EU.
Current system functions
Paola Testori Coggi, who heads the European Commission's health and consumer directorate (DG Sanco), defended the Commission's proposal.
"It functions very well. All the crises we have had could not have been avoided by a pre-market authorisation system. Why do you want to touch the things that work?" Testori Coggi said. "Let's not make the rules more strict where there isn't a need."
Roth-Behrendt said she does not understand why both the Commission and industry oppose a centralised model.
"From a purely practical European single market point of view… if I was a producer I would be interested in a centralised system as it would be easier for me not having to go through a mutual recognition procedure where you never have any idea what you end up with," Roth-Behrendt said.
Serge Bernasconi, chief executive of Eucomed, which represents the medical technology industry in Europe, said the industry would prefer a system with fewer but more certified notified bodies.
At the same time, he said the Commission should increase the number of audits. "We believe that if we do this we can maintain a decentralised system which will provide safe and effective devices for patients in a timely manner," Bernasconi said.
Franz Terwey, president of the European Social Insurance Platform (ESIP), backed Roth-Behrendt.
He said that high-risk medical devices must be subject to a rigorous assessment of their safety and efficacy.
"As we all know, the current certification system by notified bodies is insufficient in this respect as it is exposing patients to unjustified risks and harm," Terwey said.
"This is why in our opinion a centralised market authorisation for high-risk medical devices and implants is simply indispensable," Terwey added.
Terwey stressed that the administrative burdens and costs of a centralised procedure would be easily outweighed by the increased safety of the patients on one hand and the reduced recalls of devices on the other.
Monique Goyens, director general of the European Consumers' Organisation (BEUC), said "we also believe that the system should be centralised."
"We believe that the issue of a pre-market authorisation giving unnecessary delays is the wrong question. There is anyway a long delay from when a device gets a classification and until the patient has access to it," Goyens said.
Roth-Behrendt told the participants of the workshop that none of them had convinced her of changing her mind.
"This makes me happy. Or else I would be totally unsettled when I leave today. Concerning the question of a pre-market access, centralised or non-centralised… Nobody convinced me differently. Quite on the contrary. I'm more convinced now that it is necessary [to have a centralised system]," the German MEP said.
The term 'medical device' covers a wide range of products both used internally and externally by patients and doctors.
They can include sticking plasters, contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
These are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment and prevention of disease.
They are a ranked from Class I, a low-risk category that would include spectacles, to high-risk Class III items such as hip replacements and pacemakers.
- 25-29 March: First draft of the Parliament's report on medical devices to be delivered.
EU official documents
- European Commission: Amending medical devices directive regulatory proposal
- European Commission: Notified Bodies for Medical Devices
- European Commission: Medical devices: European Commission calls for immediate actions
- European Parliament: Draft Agenda: Regulation on Medical Devices (MDs) and In Vitro Diagnostic Medical Devices (IVDMDs)
Business & industry
- Eucomed: Website
- The European Consumers' Organisation (BEUC): Website