We need your help to ensure patient involvement is part of Medical Devices legislation
What’s the issue?
The European Parliament and the Council are in the final negotiations round in the review of the EU medical devices legislation. As reported in our newsletter, the Council has not included provisions for meaningful patient involvement in their position, and at this stage there is a high risk that patients (and other users) won’t be properly represented in the area of medical devices.
Unlike for the area of medicinal products where patients’ organisations are considered as partners and are involved within the European Medicines’ Agency (including through the Patient and Consumer Working Party), there is no structure for patient involvement in medical devices, and little recognition of the importance to involve the patient community. Once adopted, the new Medical Devices Regulation will be in place for at least a decade, therefore ensuring the EU adopts a more patient-centred vision in this area is essential.
We need your help in contacting your health ministry to flag the issue and convince them to support appropriate provisions for patients’ involvement. Your voice is essential to ensure patient organisations are meaningfully involved at EU level on Medical Devices, in order to convey concerns about safety and quality of devices, share our collective expertise, and to help implement measures aimed at bringing more transparency and better information to patients.
Why does it matter for patients?
Without patient involvement in any advisory or expert group in medical devices at EU level, decision are taken without consulting the end users of devices. Patients have no direct channel to convey safety or quality concerns about medical devices to the decision makers at EU level. The new Regulation is likely to contain transparency measures and provisions for better information to patients, but appropriate patient involvement is needed to ensure they are implemented in the best way for patients across the European Union.
How can you help?
If you are a national EPF member: Insert your logo and the signature of your Director/ President into the template letter below and send to your health ministry.
If you are a pan-European Member: Please circulate the letter to your members and ask for their support, as the main obstacle to patient involvement is in this case at national level, actions by national patient groups are the most likely to have an impact.
Let us know!
Please inform us through an e-mail at firstname.lastname@example.org if you send the letter, so we can keep track of Member States that have been contacted directly by their local patient community. Do not hesitate to contact us if you have any question.