This article is part of our special report Medical devices regulation.
SPECIAL REPORT / A vote in the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee over the EU's proposed new medical devices regulation, which was supposed to take place on 10 July, has been postponed until September to give lawmakers more time to work on compromise amendments.
The European Commission has tabled new rules for the approval of medical devices following a series of health scandals including a high-profile case in France involving faulty breast implants, the so-called PIP scandal.
But MEPs are divided as to how far the proposal should go in harmonising the way medical devices should be approved in future. Some committee members are worried that the new EU approval system will be too bureaucratic, while others argue stricter rules are needed to protect patients from faulty products.
Faced with political deadlock, the Parliament’s ENVI Committee decided to postpone the vote until 18 September, leaving enough time for MEPs to work on compromise amendments.
“There is no doubt for me that we need an efficient system of market access for medical devices that satisfies the highest possible safety standards in order to serve the needs of patients,” said Holger Krahmer, a German MEP from the liberal ALDE group, who is shadow rapporteur on the proposal.
“I believe that there is a lot of room for improving the current system,” Krahmer told EURACTIV.
While the Commission wants more scrutiny of existing national bodies in charge of authorising medical devices, the German rapporteur on the draft regulation, Dagmar Roth-Behrendt (Socialists and Democrats), proposed a much stricter centralised pre-market authorisation system.
Krahmer said full centralisation would make the approval system too burdensome and he prefers to “dramatically” improve the performance of existing notified bodies at the national level. The current process of market surveillance itself also needs to be re-jigged to guarantee better coordination, he said.
"This includes additional obligations on manufacturers like unannounced on-site inspections which are crucial to strengthen the current system. Furthermore, we need to enhance the availability and use of clinical expertise to guarantee the highest possible safety for the patients. Besides these, stricter requirements should apply to the competent authorities supervising the notified bodies,” Krahmer said.
But he said a centralised approval system would be going a step too far. “I do not see any benefits for patients’ safety if we just introduce a centralised pre-market authorisation at EU-level as rapporteur Dagmar Roth-Behrendt proposes,” the shadow rapporteur added.
Marina Yannakoudakis agrees. The British MEP is a shadow rapporteur on the proposal for the European Conservatives and Reformists (ECR) group. Although she thinks patient safety must be top priority, she is is opposed to a new centralised approval system, which she says will “create another layer of EU bureaucracy”.
“Our response must be proportional and limited to only ironing out the flaws and shortcomings within the current regulatory framework rather than starting again from scratch. We need to keep a member state-driven approach for notified bodies rather than handing conformity assessment, inspections and tests over to another opaque EU quango,” Yannakoudakis stated. Quango is an acronym for a quasi-autonomous organisation.
The British Conservative MEP added that innovation in the medical devices sector also has to be protected.
“Too much bureaucracy in the certification process may also cause delays in marketing devices, especially for SMEs," she said, relaying concerns expressed by the medical technology industry.
… or more ambitious
Not all MEPs agree.
Michèle Rivasi, French MEP and shadow rapporteur for the Greens, said the current approval system does not guarantee safety for patients as problematic issues have occurred, even after the PIP scandal last year.
Today's market approval system for medical devices relies on national notified bodies and this is not enough, Rivasi stressed.
She remarked that national authorities are mostly funded by the manufacturers who seek approval for their devices. Therefore, the EU does not guarantee the competence of these bodies or their subcontractors, she said.
The French MEP added that Roth-Behrendt has introduced a crucial element in her report. This relates to pre-market authorisation for certain medical devices, with sufficient pre-clinical data on quality and effectiveness of the device.
This is something the Greens have long championed.
“We must never forget that for implantable devices, ‘entering the market’ means ‘to be implanted in the patient's body.’ And medical devices are not drugs. If a fault occurs you cannot simply stop the treatment. You need to re-operate the person, with all the risks that this entails,” Rivasi told EURACTIV.
Danish MEP Christel Schaldemose, an S&D member of the ENVI Committee, said she supports Roth-Behrendt’s report as she has previously made proposals that go in the same direction.
“I’m really happy that Roth-Behrendt in her report tightens and makes the system for medical devices safer than it is today,” Schaldemose said.
“The Commission’s proposal is definitely a step forward, but Roth-Behrendt is even more ambitious. And this is necessary,” the ENVI Committee member added. “Unfortunately, we have witnessed too many bad cases with medical devices, hurting patients. We can’t accept this. We as politicians have a responsibility to protect consumers.”
In-vitro devices need more transparency
Dr Peter Liese, a German MEP from the European People’s Party (EPP), is rapporteur on a related regulation on in-vitro devices, which typically include blood tests for glucose, liver enzymes and tests for drugs.
In his report, Liese stresses the importance of reliable testing for proper diagnosis and treatment of health conditions. He favours continuing the current system by improving the functioning and supervision of national bodies.
In his report, Liese calls for more transparency in the definition of medical devices. For some devices, such as genetic tests, there must be informed consent, Liese stressed, to avoid misunderstanding and serious consequences for patient's health. The conservative MEP also recommends that single-use devices, like syringes, are placed under strict rules and should not be reprocessed.
Medicines in Europe Forum said in a statement:
"In the US, the pre-market approval for class III medical devices takes less than one year and it avoids that unsafe and ineffective devices are approved in the US. In the US, the marketing authorisation exists and they are still the leader in medical devices innovation and the leading competitor holding in excess of 40% of the world medical device market despite the high approval requirements."
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. The Parliament is currently debating the shape of new regulation.
The new regulations are scheduled for adoption later in 2013.
>> Read our LinksDossier: Medical Devices: A new regulatory landscape
- 22 Oct.: The Parliament’s Environment, Public Health and Food Safety (ENVI) Committee is scheduled to vote on its final report on the two proposed medical devices regulations (Roth-Behrendt report).
- Nov. 2013: Parliament is to vote to accept or reject the report in a plenary session.
- 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
- Environment, Public Health and Food Safety (ENVI) Committee: Website
- Eucomed: Reuse of single-use devices