Navigate through our knowledgebase

Related articles

Article

Regulatory exclusivity rights: the General Court annulled the decision of EMA to not accept a marketing authorization application

On May 5 2021 the General Court published a (lengthy) judgement in which it annulled the decision of EMA to not validate (and thus not accept and review) a marketing authorization application…

Read more

Article

Happy MDR DoA and Swixit / noTurkxit day!

As they say: this is the first day of the rest of your life, and in a way it is. The MDD is dead, long live the MDR! The (AI)MDD is no…

Read more

Article

The Enriched MDR and IVDR – finally available

Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time. It turns out that…

Read more