Medical devices include any apparatus, appliance, software, material or other article, which is used for the diagnosis, prevention, monitoring; treatment or alleviation of diseases, injury or disability. In vitro diagnostics medical devices are specific tools that provide important information on medical conditions that may assist healthcare professionals and patients in delivering correct diagnosis, in monitoring the progression of an illness or impact of a prescribed treatment, and for screening.
The existing EU legislation, dating back to the 1990s, aims at ensuring these products are safe. Medical devices have to go undergo a so-called conformity assessment to ensure they meet standards for safety and performance to receive the CE mark before they can be sold on the European market.
In 2012, the European Commission issued two proposals for Regulations (on medical devices, and in vitro medical devices ) to modernise this framework in order to keep pace with technological advances, improve safety and traceability of devices, and ensure greater transparency including towards patients and the general public.
Medical devices are of crucial, and often vital, importance for patients with chronic diseases: they can provide a major contribution to life expectancy and quality of life of patients.
- Safer medical devices: from EPF’s perspective, the future regulation should aim at achieving a high level of patient safety and quality of care.
- Improving transparency and information to patients: EPF believes that more transparency towards the public is necessary to empower patients and ensure public trust and confidence in the safety of medical devices. Patients have a fundamental and legitimate right to access information on all aspects of their health and their treatments.
- Patient involvement: EPF calls for meaningful involvement of patients, individually and collectively, in the development process for medical devices. At EU level, EPF calls for both direct involvement of patients in key decision making bodies and scientific committees, and the setting-up of a dedicated group for patients and consumers.
In June 2016, a final agreement was reach regarding the new Regulation on medical devices proposed by the European Commission and discussed in the European Parliament and by the Council of the European Union, in order to replace the EU directives adopted in the 1990s on medical devices. This agremment set new rules to ensure the safety and quality of medical devices in the EU.
EPF developed a series of information materials - fact sheets and briefings - for patient organisations and for decision makers to encourage and enable patient involvement in this area and help empower patient organisations to participate in the development, safety and quality of medical devices.
- Medical devices briefing for patients: Patient safety in the new Regulation
- Briefing on the new Medical Devices Regulation: information to patients and transparency
- Briefing on in vitro diagnostic medical devices for patients’ organisation
- Medical Devices Factsheet
In November, EPF shared recommendations on medical devices for the trilogue process, where the EU institutions will work on the final compromise for the medical devices Regulation. Our key demands in the recommendations relate to ensuring appropriate patient involvement in medical devices, to patient safety, and to ensuring patients have access to transparent and user friendly information about their devices.
In June EPF welcomed the fact that the Council has reached partial agreement on the medical devices regulation on 19 June. However some key shortcomings need to be addressed in the trilogue to ensure the final Regulation provides for safer medical devices in the EU.
In Novemberm the Regulation on in vitro diagnostics was discussed in the Council. We have updated our previous position after consultation with our members and sent it to the Council with the hope that the revised law will increase transparency on the safety of the devices and provide better access to quality information about these devices.
EPF welcomes the vote on 22 October of the European Parliament on Medical Devices with a formal statement. The adopted text maintains commitment towards more transparency and safer medical devices. However EPF urge the European Parliament and the Council to address the remaining shortcomings in the legislation and adopt it before the 2014 European elections to ensure that EU patients gain access to safer medical devices without delay.
EPF’s position was adopted in April 2013, after a full membership consultation. We also further developed our position on “in vitro Diagnostic medical devices”, which was published in September 2013. EPF will continue to liaise with MEPs to ensure the patients’ perspective is embedded in the final Regulations.
EPF participated regularly to meetings of the Medical Devices Expert Group organised by the European Commission.
EPF launched the Patient-MedTech Dialogue in partnership with Eucomed. This is the first ever structured get-together of the Medical Technology industry with different patient organisations representing disease specific organisations and national coalitions. The aim of this dialogue is to exchange perspectives on topic of common interests, such as patient safety or patient centred healthcare, to build mutual understanding.
EPF also participated to the High level conference on medical devices.
EPF and members have been involved during the EU exploratory process on the future of the medical devices sector. The process began in October 2009 with the European Commission’s aim to map out the existing public health and industrial challenges in the sector and reflect on various topics at the European level such as balancing patients’ need and financial sustainability. EPF in collaboration with the EU consumer organisation, BEUC presented a discussion paper on information to patients on medical devices during the final meeting which took place on 22 and 23 January.
EPF responded to the commission’s consultation on medical devices. This can be founded under related documents to the right.