Parliament rapporteur proposes ‘US system’ for medical devices legislation

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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.

German MEP from the Socialists and Democrats (S&D) and rapporteur on the medical devices directive Dagmar Roth-Behrendt commented on EURACTIV's story, saying that the comparison with the US system is misleading:

"The US system of approval also faces some problems and I have not used it as an example for the changes I propose. The system which I have proposed - for the authorisation of the highest potential risk class of medical devices - is based on the fact that, in the recent past, too many unsafe medical devices, such as hip prosthesis or breast implants for instance, have been inserted into the body of thousands of patients. Those devices had received an approval to be placed on the EU market."

"We know that many of these high-risk devices are not properly tested before reaching patients and health professionals, and clinical data are often too weak since the number of patients involved in the trials is regularly too limited to be representative. This is why I believe that the current EU system of approval for devices with the highest potential risk needs a complete and overall change," Roth-Behrendt added.

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.

  • Spring 2013: Members of the Parliament's environment committee to debate the rapporteur's draft report.

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