Brussels, 25 February 2019

The European Association of Hospital Pharmacists (EAHP), the European Hospital and Healthcare Federation (HOPE), the European Social Insurance Platform (ESIP), the International Association of Mutual Benefit Societies (AIM), Prescrire and the Standing Committee of European Doctors (CPME) call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed.

> Click here to download the joint statement (pdf, 209 Ko)

Since 2012, the co-signing organisations have advocated for strengthening the rules governing market access for medical devices, better market transparency and improved patient protection. Some have argued, in particular, for an independent centralised authorisation system for high-risk medical devices.

The implant files scandal is yet another warning of the urgency of the situation and of the weaknesses of the existing legislation, at the expense of patients’ safety.

Although we regret the lack of ambition of the requirements adopted in the 2017 Regulation, as stakeholders advocating in the interest of public health, we call on the European Commission not to delay the implementation of the new Regulations on medical devices and to seek the highest level of transparency regarding high-risk medical devices.

The new Regulations on medical devices and in-vitro diagnostic medical devices that were adopted in 2017 are at least a step in the right direction. In particular, the new notification process for notified bodies by the Member States, the new scrutiny mechanism for the certification of medical devices and the setting up of a European database on medical devices (Eudamed) should improve the safety of medical devices.

However, these provisions far from guarantee the same level of safety as those for pharmaceuticals, even though medical devices may carry the same level of risk for patients. They also fall short of guaranteeing full transparency of information concerning high-risk medical devices.

Timely implementation of the new rules will allow for an evaluation of their adequacy as regards solving the identified problems and for the identification of areas in need of improvement. Only once they are properly evaluated, will we be able to consider, the adoption of any further measures where needed.

In addition, we call on the European Commission to implement the highest level of transparency (especially concerning Eudamed), as public access to information on high-risk medical devices is key to ensuring traceability, vigilance and surveillance.

We remain committed to this issue and are ready to provide our support to the European Institutions where needed.

The co-signing organisations
The European Association of Hospital Pharmacists
The European Hospital and Healthcare Federation
The European Social Insurance Platform
The International Association of Mutual Benefit Societies
Prescrire
The Standing Committee of European Doctors

©Prescrire February 2019

> Click here to download the joint statement (pdf, 209 Ko)

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