Medical devices

Advocate General of the CJEU considers French ban on hemp-derived cannabidiol (CBD) contrary to EU law

Eveline Van Keymeulen

Yesterday, Advocate General Tanchev presented his long-awaited opinion before the Court of Justice of the European Union (CJEU) in Case C-663/18 (Kanavape) stating that the general ban on natural cannabidiol (CBD) in France is contrary to EU law. It is the first time that the highest European Court, including the Advocate General, has been requested Read More

Covid-19 coronavirus: EMA Fast Track Procedures for Medicines and Vaccines

Rafi Allos

The European Medicines Agency (EMA) announced on 4 May that the EMA will accelerate regulatory procedures for supporting R&D of, and evaluating marketing authorisation applications (MAAs) for, medicines and vaccines for Covid-19 coronavirus.  Further details regarding these measures are in an inventory published with the announcement.  These measures are available both for new medicines and Read More

Covid-19 coronavirus: regulatory flexibility and the importance of collaboration in the UK

Megan McMellon

Regulatory flexibility Covid-19 coronavirus  has seen medical regulators across the globe take action in order to support the pandemic response effort.  In the UK, the Medicines and Healthcare Products Regulatory Agency (the MHRA) has worked with the Department of Health and Social Care and other stakeholders to identify where regulatory flexibilities are possible and guidance Read More

BREAKING: Commission seeks to postpone implementation of EU Medical Device Regulation in light of Covid-19 crisis

Eveline Van Keymeulen

Today, on 25 March 2020, the Commission announced that “The Commission is working on a proposal to postpone the entry into force of the new Medical Device Regulation for one year. We are working hard to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the Read More

Germany lifts Covid-19 prompted export ban for personal protective equipment

Eda Zhuleku

Today the German Government lifted the export ban for personal protective equipment, including protective masks, that had been instated by the general decree (Allgemeinverfügung) dated 4 March 2020 as amended on 12 March 2020. The purpose of the export ban (to both EU and non-EU countries) was to secure the supply of personal protective equipment in Read More