Medical devices

Can the Italian healthcare system process sensitive personal data without explicit patient consent?

Emilio De Giorgi

On 27 March 2018, a draft of the legislative decree (Draft Decree) that is expected to replace the Italian Privacy Code following the entry into force of the EU General Data Protection Regulation (GDPR) was published.  The Draft Decree anticipates important novelties regarding the way in which medical facilities will have to handle the processing Read More

Getting ready for the EU MDR: Classification of medical devices

Eveline Van Keymeulen

In this second post of our “Getting ready for the MDR” series, we look at how the MDR will affect manufacturers in classifying their devices according to the newly introduced rules and classification criteria. Rules on medical device classification will not radically change under the upcoming regulatory system, which will apply as of 26 May Read More

Getting ready for the EU MDR: Timelines for manufacturers

Marco de Morpurgo

In the first post of our “Getting ready for the MDR” series, we have a look at the key timelines that manufacturers need to be aware of as they prepare for the application of the EU Medical Devices Regulation (MDR). Time is going by fast and the new MDR will soon become applicable. Its application Read More

Belgium to strengthen role of e-health apps in patient healthcare

Veerle Pissierssens

The Belgian Minister of Health has announced in a press release that she is seeking to integrate mobile medical applications (e-health apps) into the Belgian healthcare system. In order to ensure the quality of such e-health apps and the safety of patients, these apps will be evaluated under a specific scheme (Evaluation Scheme) and some Read More

ANSM recommendations prohibit use of umbrella brands with respect to health products in France

Eveline Van Keymeulen

Last week, the French National Agency for Medicines and Health Products Safety (ANSM) published its final recommendations for applicants and holders of marketing authorisations (MA) on the choice of medicinal product names (the Recommendations). The Recommendations were issued following a public consultation by the ANSM in October-November 2016 (see our previous blog post: ANSM opens Read More