Update on the draft report on medical devices

Rapporteur Dagmar Roth Behrendt MEP (S&D, Germany) published on 12 April the draft report on the proposal for a Regulation on Medical Devices. It takes on board some of the key concerns we have expressed in our position on medical devices but some gaps remain.

The report proposes a pre-market approval procedure for high risk devices (Class III devices). It suggests establishing a Committee for the Authorisation of Medical Devices within the European Medicines Agency (EMA) to oversee the process, where patients would be represented.

EPF initially supports the Commission proposal to put in place a scrutiny mechanism as as it will empower the authorities to have a 'second look' at individual assessments, ensure they are aware of new high risk devices coming on the market, and give them opportunity to make their views heard before these devices are placed on the market.

However we believe that pre-market approval can also be a sound solution for further control of high risk devices. However EMA must be granted adequate resources and expertise to carry out this task without creating undue delays for patients’ access to innovative devices. 

What we support

Changing the authorisation system alone will not improve safety and quality of devices. We support other essential issues addressed by Mrs Roth Behrendt’s report, as follows:

• Patient involvement: The draft report offers to involve patients together with other stakeholders in an advisory committee. This group would discuss borderline classification and other implementation issues. Patients would also be represented through the Committee for the Authorisation of Medical Devices mentioned earlier.
• Clinical evaluation: The report provides for further publication of information on clinical investigation which we are pleased with. It mentions clearly that there should be an ethic review where patients should be involved.
• Vigilance: We are encouraged by the strengthening of the proposal’s wording to allow for direct reporting of incidents by patients and healthcare professionals.

Remaining gaps

We regret the draft report states that devices should be classified in principle as re-usable, unless the manufacturer proves this is unsafe. From our perspective these devices should only be re-used if there is sufficient evidence that it is safe for the patients, and with clear standards and guidelines. We call on the European Parliament to place patient safety first when considering this issue, over economic considerations.

We also call for more users’ involvement. The Regulation needs to put in place a Patient and Consumer Working Group for Medical Devices. Patients’ unique perspective on the risks-benefits balance needs to be taken into account. The working party could also contribute to the implementation of the Regulation e.g. granting adequate access to information about medical devices to the public.

Medical devices need more transparency at all stages from clinical evaluation to post market surveillance.  We call on the European Parliament to set stronger requirements to ensure patients and healthcare professionals have access to all information they need through the databank Eudamed.

We will continue liaising with MEPs on these points and will provide recommendations from the patients’ perspective ahead of the vote in the ENVI committee in the coming months.

For more information, please contact our Policy Officer, Laurène Souchet, at laurene.souchet@eu-patient.eu.