July 2016


In May 2016, agreement was reached between the EU Council and the European Parliament on a new regulation for medical devices, designed to enhance the safety of medical devices while allowing patients to benefit from harmonised rules for timely and innovative healthcare solutions.

Devices will 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 a central database, the European Databank on Medical Devices (Eudamed).

Devices will 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 a central database, the European Databank on Medical Devices (Eudamed).

The new regulation will also introduce stricter rules for notified bodies that assess medical devices, ensuring they have qualified personnel available to conduct factory inspections. The new regulation will hold manufacturers responsible for continuous follow-up on the quality and safety of devices placed on the market, mandating manufacturers to monitor and act promptly if emergencies arise.

The agreement still needs to be formally adopted to conclude the legislative process which is expected in late 2016. The proposed final text for the regulation is available in the links section.

ESR successfully renews its membership of the EMA Healthcare Professionals Working Party

We are pleased to announce that the ESR has renewed its membership of the European Medicines Agency (EMA) Healthcare Professionals Working Party (HCPWP) for the term 2016-2019. First established in 2013, the HCPWP provides its expertise to the EMA Management Board and Scientific Committees in all aspects related to medicines. Membership of the EMA HCPWP enables the ESR to be actively involved in the activities of the EMA and also facilitates a direct dialogue with the regulators.

For further information follow the links section.

Report of the Global Summit on Radiological Quality and Safety 2015 published

The Global Summit on Radiological Quality and Safety (GSRQS), jointly organised by the American College of Radiology (ACR) and the European Society of Radiology (ESR), focused on practice improvement, customer service, professional issues, and safety. Around 60 experts from international, regional and large national societies and organisations participated in the two-day summit held on October 10-11, in Barcelona.

The report of the summit has recently been published in Insights into Imaging and can be downloaded in the links section.


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