EU

General Court explains the concept of environmental law in the Aarhus Convention and annuls Commission decision on products containing genetically modified soybeans

Tine Carmeliet

On 14 March 2018, the European General Court (General Court) ruled that non-governmental organisations (NGOs) have the right to request that the European Commission (Commission) review a decision that authorises the placing of genetically modified food and feed on the market. The background to this judgment relates to a Commission’s 2015 decision in which the Read More

Rise of New CRISPR Inventions: the toolbox of research applications for CRISPR-based systems continues to expand

Daniel Lim

Although much of the reporting around CRISPR tends to focus on its cleavage based ability to knock out or repair targeted sequences of DNA in a genome, some of the most exciting developments in the CRISPR field do not involve gene editing at all. Many of these advances are already being put into effect in 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

Innovators can protect data exclusivity in Concerned Member States following a decentralised procedure

Jacqueline Bore

The Court of Justice of the European Union has ruled that the holder of a marketing authorisation for a reference medicinal product in a decentralised procedure does have the right the challenge in the courts of the concerned Member States the grant of a marketing authorisation for a generic medicinal product on the basis that 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