What do you want to know about your medical device? Have a say on future EU guidance for patient information!
The new Medical Devices Regulation
The European legal framework for medical devices and in vitro diagnostics will become more binding and stringent in the coming years, as two new regulations on medical devices were adopted in April 2017 and entered into force in May 2017, replacing the previous directive. The new rules will only apply after a transitional period. Namely, three years after entry into force for the Regulation on medical devices (spring 2020) and five years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
The Summary of Safety and Clinical Performance (SSCP)
A positive innovation in the new Regulation for Medical Devices is that, for high-risk class III medical devices and implantable devices, manufacturers will need to provide a publicly available summary of safety and clinical performance (Article 26).
The Summary of Safety and Clinical Performance (SSCP) will be an important source of information for intended users - both patients and healthcare professionals - to enable them to make informed decisions about the identified medical device. The SSCP for medical devices is comparable to the European public assessment reports (EPAR) for medicines.
The summary of safety and clinical performance is not intended to give general advice on the treatment of a medical condition or the use of the device. This summary of safety and clinical performance is also not intended to replace the Implant card or the Instruction For Use to provide patients with the information on the safe use of the device.
The summary will need to be written in a language that is clear to the user, including “where relevant” to patients.
The Regulation does not specify precisely for which devices or categories of devices it is considered “relevant” that the summary needs to be written in a patient-friendly way.
EPF is a member of the working group developing the SSCP template and SSCP guidance document. The WG proposes to provide specific information intended for patients in different EU languages, within the SSCP, at the end of the document. A more extensive summary of the safety and clinical performance of the device is written in English for health-care professionals and can be found at the beginning of this document.
Once the new regulations on medical devices apply, this summary will be publicly available on the new ‘EUDAMED’ medical devices database.
What do you think?
As a member of this working group, we want to ensure that the sections of this new summary, intended for patients, is indeed written in a patient-friendly and that the information included is relevant to the patient.
In this respect, we are calling on your support to review this SSCP guidance and template document, in particular the section on additional information for patients highlighted at the end of the document attached.
Please review the draft SSCP guidance and template. 4 questions to consider have been included at the end of the attached draft SSCP document.
Please send us your comments and proposals in track changes, to firstname.lastname@example.org by 21 March COB. Please note that EPF has had no influence on the relatively short deadline which has been set by the Member State-led process.
Many thanks in advance for your support!