AESGP Conference

1. 08.10.2014
Brussels
Nicola Bedlington, EPF Secretary General
ADJUSTING THE MEDICAL DEVICES’ LEGISLATION TO PATIENTS’ NEEDS

2. •Independent, non-governmental umbrella organisation set up in 2003
•OUR VISION: All patients in the EU have equitable access to high quality, patient-centred health and social care
About the European Patients’ Forum
•OUR ROLE: United patients’ voice in EU health and social policy
•OUR MEMBERS: disease-specific EU & national coalitions – 64 member organisations

3. •Medical devices are of crucial importance for patients with chronic diseases
•Contribute to life expectancy and quality of life
•We welcome the review of the Regulation towards safe effective medical devices.
Our perspective
•Adjusting the medical device legislation to the needs of patients mean placing patient safety first and putting in place legislation that empowers patients.

4. •Proposal published in September 2012 – EPF active in the debate from the outset
•Patient safety first
•Users’ involvement: emulating the model of patient involvement developed by the European Medicines Agency
•Transparency throughout the system to empower patients
•Promoting equitable access to high quality medical devices for all patients throughout the EU.
Priorities in the review

5. •Regulation must enable better clinical evaluation & investigation to ensure innovations are safe and meet patients’ need
•Better scrutiny for all higher risk devices through expert committee and clearer responsibilities for notified bodies => support to the European Parliament position
•Better vigilance and post market surveillance system, to put in place a real patient safety culture in Europe & with patient direct reporting of incidents
Patient safety

6. •Substance-based devices can help relieving adverse events caused by treatments for chronic diseases or long-lasting conditions,
•Putting patient safety first by ensuring these devices comply with the right requirements in both the medical devices and the medicine legislation.
•The rationale: since they are absorbed or dispersed in the body, these products might bear additional risks of toxicity or side effects.
•But flexibility needed to ensure products are not unduly placed in the higher risk category.
Safety for substance based devices

7. •Important to ensure consistency in classification
•Misleading for patients if a product is considered a medical device in one country and a medicinal product in another,
•All patients in Europe need to be guaranteed the same level of safety
Borderline devices
•Appropriate cooperation with EMA +involvement of users (including patients) in discussions on borderline cases.

8. •More transparency towards the public is necessary to empower patients and ensure public trust and confidence in the safety of medical devices.
•Need for good quality lay information about safety and performance of the device, and also access to information about post market surveillance
•Key measures have been introduced by institutions during the debate to: prohibit misleading information, give access to vigilance and clinical investigation information etc…
•Patients need to be involved in implementation of these measures (e.g. in defining the core elements of summary of the safety and performance report of high risk devices)
Patient empowerment

9. •Patients are experts : clear framework to involve them and harness their expertise missing
•Patient can be empowered through involvement in vigilance (direct patient reporting)
•and in assessing clinical investigations => towards a more patient centred model of innovation
Patient involvement
•to ensure medical devices correspond to the needs of patients, we think it is vital that patients are involved in medical devices regulation as they are in regulation for medicines: dedicated group + key decision making bodies

10. •EPF welcomes the first reading of the European Parliament but still believe some work is needed
•We call on the Council to take into account the patients’ perspective in the review of the framework for medical devices
•EPF is committed to working closely with the European Institutions and stakeholders to ensure that medical devices and substance-based devices in the EU are safe, high quality, accessible and meet patients’ needs
Conclusions

11. /europeanpatientsforum
/eupatientsforum
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info@eu-patient.eu
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