EU & International Affairs News

On 14 July 2016, with the goal of ensuring overall safety and patient care in the MRI environment, a coalition of international MR organizations has published a blueprint to guide the creation of three safety positions within radiology departments or imaging centers.

The document, published online in the Journal of Magnetic Resonance Imaging, outlines the duties and requirements for an MR medical director/MR research director, MR safety officer, and MR safety expert. All three people would...

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...

This month’s update on EU affairs includes the latest on ESR iGuide, the ESR’s clinical decision support system, the EU General Data Protection Regulation and the European Commission’s proposal for creating a Digital Single Market in Europe.

ESR iGuide – clinical decision support for European imaging referral guidelines

The ESR is one of 30 organisations participating in the European Commission's new eHealth Stakeholder Group for the period 2016-2018. The group will provide reports, opinions and relevant data, and act as a consultative body for the European Commission.

In addition, the Intersociety Working Group on MR Safety, which was co-founded by the ESR, has recently published a document providing recommended responsibilities for the management of MR safety.

Following a call for expression of interest, the European Commission recently selected...

Following the numerous studies published in 2015 on the hypersignals in the dentate nucleus and globus pallidus in patients having received several doses of Gd chelates, a major safety concern on MRI contrast agents has again emerged. In January 2016, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed these publications. Although no adverse effects relating to gadolinium brain deposition have been reported to date, the PRAC will carry out an in-depth review of the risk of brain deposits and of the...

Patients and professionals met at the European Congress of Radiology (ECR), held in Vienna on March 2-6, to discuss the best ways of implementing a patient-centred approach in clinical radiology.

The aim of the ECR session Patient-centred care in clinical radiology: do we really put our patients first?, held on March 5, was to explore concrete examples of best practice in implementing patient-centred care in the radiology department and how these might be replicated by providing both the patients’...

In 2012, the European Commission put forward a proposal revising the existing data protection legislation aiming at a harmonisation of the standards for data access and processing.

Following Edward Snowden’s disclosures on US and British mass surveillance of digital communications in 2013, the European Parliament revised the proposal, adding several amendments in order to increase the protection of personal data.

These amendments led not only to a heated debate at EU member state level, particularly with regard to...

In 2012, the European Commission put forward a proposal to revise existing data protection legislation, to harmonise standards for data access and processing. After prolonged discussions, the Council and the European Parliament have finally agreed on a proposal to ease restrictions on the use of health data for research purposes, which was welcomed by the European Council of 17-18 December 2015.

Agreement reached on European Commission’s EU data protection legislation

In 2012, the European Commission put forward a proposal...

This issues's comprehensive EU affairs update includes news about EU cancer initiatives, application for membership of the Multidisciplinary European Low Dose Initiative (MELODI), the European Commission's call for scientists to join the non-food Scientific Committees for the term 2016-2021, and news about Integrating the Healthcare Enterprise (IHE) Europe Profiles.

Update on EU’s cancer initiatives

In 1985, the European Council first launched a European action programme against cancer.
To this day, the EU encourages cooperation in relation to cancer...

This month's comprehensive EU affairs update includes news about the EU medical devices regulation, our "radiologist's summary" of the Basic Safety Standards directive, and continued efforts to raise awareness of patient safety and quality of care.

Update on EU medical devices regulation

After one and a half years of negotiations, the EU Council reached agreement on a general approach (please see the Medical devices press release in the links section) regarding the medical devices and in-vitro medical devices regulations at...