More investment needed with one year to go to restore the trust and confidence of patients and the public in the regulation of medical devices in the EU

Sunday 26 May marked the 365-day countdown to the application of the new EU Regulation on medical devices. To mark this critical milestone, earlier this month, EPF organised a webinar for its members, European and national patient organisations which aimed to present an update on the status quo, highlighting progress that had been made so far but also concerns and next steps for the coming year in terms of ensuring the optimal operationalisation of the new regulatory system.

Patients with chronic conditions rely on medical devices to improve their health and quality of life. Patients have a fundamental right to expect that the devices they use are safe, after being authorised for use in the EU. The recent revelations of harm caused to patients by inadequately tested devices, though not new, served as a reminder that the current system is in urgent need of improvement.

The new Regulation (2017/745) promises[1] to bring important changes for patients such as stronger safety requirements particularly for high-risk devices, strengthening transparency and strengthening post-market surveillance.

EPF has engaged actively throughout the legislative process and continues to do so in this implementation phase to prioritise and ensure patient safety, equitable access, patient involvement, greater transparency in the system are prioritised.

Limited regulatory capacity and manpower threaten the swift and effective implementation of the new regulations. EPF has previously warned about readiness concerns and the slow speed of implementation, which may mean a risk of delay in (re) certification of products and ultimately a delay in access for patients but also a discontinuation of many existing medical technology products. In the face of uncertainty about how to transition their products, manufacturers may decide to “retire” devices that are not essential to them. This eventuality is clearly concerning for EPF.

EPF calls for effective implementation to ensure patient safety

In advance of the June Health Council, EPF calls for Member States to free up investment and increase the capacities of the Commission and national competent authorities to speed up the designation of notified bodies to ensure access to medical technologies and patients’ safety come May 2020.

Increased capacity and expertise will also benefit the successful implementation of many other important elements of the system, such as quality guidance, public access to information and a transparent regulatory framework. This is vital to restore the trust and confidence of patients and the public in the way medical devices are regulated in the EU.

EPF intends to play its part in ensuring optimal implementation, advising and assisting in the implementation of the regulation, putting what matters to patients first. Similarly, EPF continues to build capacity within the patient community, encouraging patient participation at both European and national level. Later this year, EPF intends to organise a webinar with the European Commission to prepare patient organisations to communicate about the about the upcoming application of new rules and rights relating to medical devices.

For more information, contact Katie Gallagher.

[1] We speak of only one regulation although there are two regulations. The other one, Regulation (EU) 2017/746, on in vitro diagnostic medical devices will only apply as of 2022.