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Dear Anonymous, the MDD is not directly applicable in the Member States. The Directive is transposed into national laws and advertisement is typically regulated at national level. Some countries have strict and detailed rules (e.g. France) and other have less strict regulations. Overall, advertisement ...

Hello Anonymous, In my opinion, the role of the FS is that of the organisation they belong to. The importer has put the product through customs and placed it on the EU market (by definition of importer). If the FS belong to the same organisation of the importer, then the importer is a distributor as ...

We are a Swiss-based manufacturer of a single-use, sterile medical device for which we hold a Chinese registration certificate for Class III imported medical devices. For various reasons, we would like now to ship in bulk (the import license includes bulk packaging) and do the final packaging configuration ...

Hi Victoria, Contract manufacturer in general would not need to certified according to the MDR and most of the QMS changes required by the MDR do not affect them. However, ​they will need to provide you with the elements required by Annex II (Technical Documentation) and in particular section 3: 3. ...