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Advancing healthcare policy

Medical devices and Europe

Advancing healthcare policy

Medical devices and Europe: Actions

At certain key points, citizens can bring their actions to bear upon European deputies and upon the ministers of Member States.
Below is a recap of our actions.

Drug-device combinations: EMA's consultation on quality requirements is an opportunity to strengthen patient safety (August 2019)

Drug-device combinations play a major role in preventing medication errors. The public consultation relating to the draft Guideline for the quality requirements for drug-device combinations is an opportunity for EMA to significantly strengthen its expertise in these health products and patient safety. Prescrire offers a series of recommendations mainly aimed at protecting children, elderly patients, and patients undergoing high-risk hospital care. Read on...
A call for timely application of the new rules on medical devices and complete transparency concerning high-risk medical devices with public access to Eudamed (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. Read on...
"Implant Files" : Campaign for an effective marketing authorisation for high-risk medical devices (December 2018)

In a joint press release, several French associations, including Prescrire, join forces to condemn the health authorities’ failure to adequately oversee the trade in high-risk medical devices. Read on...
EU Regulation on Medical Devices: Patient safety should be of paramount importance (November 2013)

In a joint letter, AIM, the ISDB and MiEF call upon the Representatives of Health Ministers of Member States to improve the EU Medical Devices Regulation in order to better protect patients’ safety. Read on...
EU Parliament missed needed improvements in the medical devices legislation (October 2013)

In a common press release, AIM, l'ISDB and the Medicines in Europe Forum observe that, although some small improvements have been made on the assessment of high-risk medical devices, major flaws remain in the legislation. Read on...
Medical devices: joint communication campaign (July 2013)

True or false? Four factsheets answering some key questions on medical devices. A joint communication campaign by ESIP, AIM, ISDB and MiEF. Read on...
Medical devices legislation: regaining the trust of European citizens (May 2013)

A joint press release by AIM, ISDB and MiEF supports the draft report by MEP Roth-Berendt, rapporteur for the Environnent and public health (ENVI) Commmittee, as this draft report improves upon the European Commission’s proposal for a Regulation on medical devices. Notably, the draft report includes greater protection for patients by strengthening the evaluation of high-risk medical devices before marketing approval. Read on...
Medical devices: high-risk devices should be made subject to approval at European level and the rights of patients harmed should be improved (October 2012)

In a joint position paper, the Association Internationale de la Mutualité (AIM), the European Social Insurance Platform (ESIP), the International Society of Drug Bulletins (ISDB) and the Medicines in Europe Forum (MiEF) argue that high-risk medical devices should be made subject to approval at European level, and that the rights of patients harmed should be improved. Read on...