June 2016

On 25 May 2016, the Dutch Presidency of the Council of the European Union and the European Parliament have reached a draft agreement on the medical devices and in vitro diagnostic medical devices regulations. This agreement comes after a four-year long legislative process initiated by the European Commission’s 2012 Proposal for a Regulation on medical devices and Proposal for a Regulation on in vitro diagnostic medical devices to replace the three existing medical devices directives. The Commission had considered a revision of the existing regulatory framework necessary to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative health care solutions.

Devices will in future become fully traceable and patients receiving implantable devices must be informed of the product’s key facts. Non-confidential information will be made available publicly through the central database European Databank on Medical Devices (Eudamed).

Serge Bernasconi, CEO of MedTech stresses the importance of collecting necessary funds from public and private stakeholders(e.g. Governmental Health Agencies, Industry Representations) to fully implement the agreement, and confirms that industry bodies EDMA and Eucomed will actively support their members in the challenging transition towards a new, less bureaucratic regulation.

The European Patients' Forum (EPF) would have expected a closer involvement of patients, but still welcomes the agreement as a means to implement stricter controls on pre-market assessment and post-market surveillance of medical devices, resulting in better safety standards for patients.

The 25 May trilogue agreement still needs to be formally adopted by the Council and the Parliament to conclude the legislative process. It is also important to note the transition periods for the new rules, which will apply three years after publication of the medical devices regulation and five years after publication of the vitro diagnostic medical devices regulation.

More information on how radiological equipment is affected by the new regulation will follow when the legislative texts are published.