After my blog about guidance document MDCG 2021-27 in which I argued why in my view it defines placing on the market wrongly by requiring transfer of a property right as a condition for placing on the market, a lot of discussion started. I even received an email from the European Commission commenting on the […]
Life, as they say, is like a box of chocolates: you never know what you’re going to get. MDCG guidance documents are very much like that too. Even if you’ve seen them coming in the consultation phase the end result may still surprise you. Some are really good, some are really good and complex, some […]
I attended the Informa PMS surveillance conference in Berlin on 27 and 28 February, and thought I’d share some of the interesting things I picked up there because to me it was a very good conference with some of the best EU experts sharing their knowledge. There were also some easter eggs of information. The […]
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo calls them in an interesting analysis of the IVD regulation proposal: the MAID (manufacturer, authorized representative, importer, and distributor). Both the IVD and medical […]
In the series of articles on this blog discussing parts of the proposed EU medical devices and IVD regulations I am taking a look now at economic operators, or as Maurizio Suppo calls them in an interesting analysis of the IVD regulation proposal: the MAID (manufacturer, authorized representative, importer, and distributor). Both the IVD and medical […]