Standardisation request for MDR and IVDR refused – now what?

A new blog post, a new step in the soap that is the non-transitional period of the MDR and the IVDR. I have jokingly paraphrased the absurdist painter Magritte by saying “céci n’est pas une période de transition”. I’m contemplating starting a T-shirts business with memes for the MDR and IVDR, with that meme and others, like “Regulatory Cassandra” and “I worked myself into the ground to meet the MDR DoA and all I got was this one year delay which is not a delay actually”. And of course for [...] « Read the rest of this article on medicaldeviceslegal »