This article is part of our special report Medical devices regulation.
German centre-left MEP Dagmar Roth-Behrendt is proposing a centralised authority to approve medical devices before they are sold on the EU market.
In her draft report on a new medical devices directive, Roth-Behrendt (Socialists and Democrats) said the procedure for getting the devices on the market in the EU has shown substantial weaknesses over the past years and needs a shift.
These weaknesses include a lack of transparency and swift approval and placing on the market despite insufficient investigations on patients and therefore insufficient clinical data. This is putting patients at risk, the rapporteur said.
Therefore, Roth-Behrendt is proposing a system like in the United States, where the Food and Drug Administration (FDA) has a pre-market approval (PMA) process for so-called 'Class III' devices. These are medical devices which represent the highest risk to public health, or "novel technologies".
"For such devices, your rapporteur proposes to introduce a new marketing authorisation procedure, at centralised level for devices of an innovative nature and at decentralised level for the other devices mentioned above," Roth-Behrendt said in the report.
Under the Commission proposal of a revision of the directive, national bodies would be responsible for approvals but would be able to review, scrutinise and comment on assessments performed by others.
Industry fears unnecessary delays
The industry said the draft report is a step backward for patients, healthcare systems and Europe.
"Industry continues to strongly believe that a move towards a centralised, pre-market authorisation procedure is not the right way forward," the European medical technology industry association Eucomed stated.
Eucomed stated that many scientific reports and studies clearly indicate that a centralised pre-market authorisation system for medical devices, similar to the one in the US, will deliver no additional safety benefits for patients. Instead, it will cause unnecessary delays of up to three years in lifesaving medical devices reaching patients.
In a response to the ongoing discussions in Parliament, Eucomed said it has now launched the campaign “Don’t lose the 3”.
The campaign "showcases the advantage that patients in Europe currently enjoy" and explains what changes the industry believes need to be made to the current European system in order to ensure timely access to lifesaving medical devices.
Roth-Behrendt will now enter discussions with MEPs in the Environment, Public Health and Food Safety (ENVI) committee.
Members of the committee will debate the report, table amendments and vote on the final version, after which it will be voted on in a plenary session of the Parliament.