News
Ensuring stronger rules and transparency on medical devices |
27-02-2019 |
EV
Public health stakeholders call for timely application of new medical devices rules
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.
The "Implant files" scandal has been a major warning sign of the weaknesses of the current legislation in the field of medical devices, at the expense of patient's safety.
Since 2012, 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) have advocated for a strengthening of the rules governing market access for medical devices, with more transparency and better patient protection.
The new Regulations on medical devices and in-vitro diagnostics adopted in 2017 are at least a step in the right direction. However, these provisions far from guarantee the same level of safety as those for pharmaceuticals.
Therefore, the co-signing organisations call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed.
Find out more in our joint statement.
