Attentive attendees of my presentations will have remarked in my presentations about economic operators that essential parts of the general Goods Package were being amended and that this may affect companies in the medical devices space. I now present to you Regulation (EU) 1020/2019 of 20 June 2019 on market surveillance and compliance of products and […]
After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first. Some history But first, for those who are […]
The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what the European Court’s recent judgment in the Lycocentre case confirms. Confirms? Yes, it basically confirms what we already knew and that is that […]