Focus on the authorised representative

Last week we saw publication of the new MDCG guidance on the authorised representative under the MDR and the IVDR, MDCG 2022-16. My first impression: much about the ‘what’ and not so much about the ‘how’, resulting in a guidance that, in typical MDCG fashion, repeats a lot of the law back at you without providing a lot of additional actual guidance that fills in the blanks. Nevertheless, there is certainly some interesting content in the document. More in general my impression is that the doc [...] « Read the rest of this article on medicaldeviceslegal »