The European Parliament on Tuesday (22 October) voted to improve the control on medical devices via strengthened traceability rules and transparency of information for patients and medical staff, but without creating additional burdens for small manufacturers.
MEPs meeting in Strasbourg proposed to give patients and health professionals better access to clinical data, that only a permanent team of in-house experts can give 'CE' proof of conformity marks to medical devices and that the traceability of reprocessed devices should be improved.
The strengthening of the EU rules on medical devices follows a series of health scandals, including the fraudulent use of silicone in breast implants; the so-called PIP scandal.
Dagmar Roth-Behrendt, the German MEP from the Socialists and Democrats (S&D) group responsible for medical devices the legislation, said that MEPs should push through regulation that will make sure that doctors have access to the best possible products for their patients.
"To date, doctors have been telling us that hundreds of hip replacements are defective and have to be taken out again, with huge expenses for the health systems and suffering for patients. We need a better system," Roth-Behrendt said.
Keeping current EU approval system
However, the plenary vote in Strasbourg did not call for greater change to the EU's current medical devices approval system which gives notified bodies in member states the overall responsibility.
A month ago, the Parliament's Environment, Public Health and Food Safety (Envi) committee called for a system with special notified bodies designated by the European Medicines Agency (EMA), in order to assess a select number of devices that pose the highest risk. For these devices, case-by-case checks will be conducted by a new expert body, the Assessment Committee for Medical Devices, the Envi committee says.
Industry has said for a long time that changing the approval system would create unnecessary burdens and potentially kill off many European small and medium-sized enterprises (SMEs).
Holger Krahmer, a German MEP from the Alliance of Liberals and Democrats for Europe (ALDE), said that his party had improved the committee text for an efficient authorisation system which ensures the highest patient safety and at the same time strengthens the capacity for innovation of the European medical technology sector.
Serge Bernasconi, chief executive of the European medical device industry association, said that the industry had witnessed "positive developments" in the Parliament between the committee phase and the plenary vote.
"We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices,” Bernasconi added.
Monique Goyens, the director general of the European Consumer Organisation (BEUC), added that she had expected MEPs to take a bolder stance on granting consumers access to safer medical devices.
"Although the surveillance of devices once they are implanted will be considerably beefed up, the same cannot be said about the pre-market phase. Despite our repeated calls, there will still be no thorough evaluation of the risks and benefits of a device before it is used. Under the current system, consumers will continue to be used as guinea pigs," the director general said.
The Greens public health spokesperson, French MEP Michèle Rivasi, added that while the Parliament vote was a step forward in addressing the previous health scandals, the Greens regretted that the outcome of the vote did not include provisions on full pre-market authorisation on high-risk devices.
In a separate legislation on in-vitro medical devices, such as diabetes self-tests, HIV and DNA tests, the Parliament called for an ethics committee to be set up and introduced provisions for the informed consent of patients and genetic counselling.
French MEP Françoise Grossetête from the European People's Party (EPP) said: "The new EU rules will strengthen the accreditation criteria for notified bodies and tighter controls with random audits in the factories will ensure the safety of users of medical devices. If they do not perform these checks, organisations may face suspension or revocation of their status. The best notified bodies will be selected to mark the high-risk medical devices."
Green public health spokesperson Margrete Auken said: "We welcome the support of MEPs for Green proposals to ensure transparency on the results of clinical investigations of high-risk medical devices. This is crucial for the credibility of and public trust in such investigations. The clinical investigations will also be subject to the approval of an ethics committee. This provision, which would ensure the EU complies with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, is essential for the credibility of clinical investigations"
Medical devices are defined broadly and can include anything from sticking plasters to contact lenses, pregnancy tests, dental filling materials, X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
Following a huge health scandal involving faulty breast implants sold around Europe, the European Commission published proposals in late 2012 for a new regulatory regime for medical devices.
On 22 October 2013, the Parliament's plenary voted to open negotiations with the Council on the legislation of both medical devices and in-vitro medical devices which will take place in the coming weeks.
- Public health: Revision of the medical device directive
- Environment, Public Health and Food Safety (ENVI) Committee: Draft report on medical devices
- Environment, Public Health and Food Safety (ENVI) Committee: Draft report on the proposal for a regulation of the European Parliament and the Council on in vitro diagnostic medical devices