The European Commission has proposed a new regulation on medical devices in Europe, following the 2012 health scandal involving breast implants. But the new proposals do not go far enough, says the Parliament's rapporteur on the issue.
German MEP Dagmar Roth-Behrendt, from the Socialists and Democrats (S&D) group, said she did believe that the EU's current system is satisfying or that the Commission's proposal is good enough.
The Commission has proposed a system where member states will be able to review, scrutinise, and comment on assessments performed by notified bodies.
This is given the provided assessment meets certain criteria, such as high-risk (Class III) devices that represent public health concerns, "novel technologies" and files from notified bodies with a history of significant discrepancies.
However, Roth-Behrendt said she would want to look into both the classification system, pre-market approval and the notification system.
"I think our friends at the Commission need some help from the European Parliament just to make the system sound for patients as well as for procedures. I do not believe the system for procedures is good," the MEP said at a public debate on medical devices in the European Parliament on Tuesday (26 February).
The current system is not satisfying for consumers, according to Monique Goyens, director-general of the European Consumers' Organisation (BEUC).
"Consumers expect and have the right to expect that the medical devices that they are using, exposed to or which is even implanted into their bodies have been submitted to a proper risk assessment and are being risk managed. In reality the current legislation is less strict than for medicines and even sometimes for food," Goyens said.
'Industry also needs to flourish'
But Paola Testori Coggi, who heads the European Commission's health and consumer directorate (DG Sanco), defended the Commission's proposal, saying the EU Executive considers the new proposal a priority.
Testori-Coggi said the most important thing will be to reconcile the highest possible level of patient safety with the industry's competitiveness, arguing that an innovative industry was a favour to the patients.
"It's clear that Europe is a place where medical devices flourish. We have proven that Europe is a place where medical devices have been innovative and the right answer to the patient," Testori Coggi said.
"So we must be able to maintain this medical technology because it's central to ensure the sustainable healthcare system because today, we all have the problem with a sustainable healthcare," she said.
Serge Bernasconi, chief executive of Eucomed, which represents the medical technology industry in Europe, said everyone was in favour of a strong traceability system.
"The industry wants a different and safer system. The industry will not accept a system where incidents such as the PIP case can happen again. We want a system which is quicker in detecting the long-term safety concern and the industry cannot accept notified bodies that give the impression to find industry more important than patients like reported by the British Medical Journal," Bernasconi said.
PIP refers to the silicone breast implants manufactured by the now-defunct French company Poly Implant Prothèse.
US approach or not
The key issue, Bernasconi said, was whether to opt for a centralised or a decentralised approval system. In the United States, the Food and Drug Administration controls a pre-market approval (PMA) process for Class III devices, the highest risk of three possible classifications.
"We as the industry does not believe in a centralised approval system, and research has proven it does not work for patients and industry."
"In the US, the FDA has tried to manage the approval process, and what is their track record? Compared to Europe, their system is just as safe as ours, but leads to patients waiting 3-5 years longer than Europeans. Some patients really don't have that long," Bernasconi said.
Even though the industry supports the Commission's proposal to improve the decentralised system by regular control of the notified bodies, the proposed scrutiny procedure is found to be inappropriate.
"We are not against the principle of scrutiny, but against the mechanism of the proposal. It's not systematic, predictable, will not lead to increased safety and will generate unnecessary delays," Bernasconi stressed.
Werner Siebert, medical director of the Vitos Orthopedic Clinic in Kassel, said he spoke on behalf of the patients:
"There must be a unique device identification system. We find again and again in our daily work that the implants are not clearly identifiable and the device identification is not the same. This also applies to instruments and implant related tools. What we get on the table is not always what it says on the paper on the outside. This should be regulated."
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.
- 24-25 April: Responsible authorities for medical devices (CAMD) to meet in Dublin.
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