Mark 5 May 2017 in your calendar – this date will be a landmark for EU medical devices law because the MDR and IVDR will be published in the EU Official Journal.
This means that the MDR and IVDR will enter into force on the twentieth day following that of their publication and from that date the transitional periods under the regulations will start.
And the clock will then start ticking officially – if you still are not feeling a sense of urgency about getting ready for their implementation now is a good time to start feeling that urgency.
As I have been repeating like a broken record: not being compliant under the regulations in time equals to no more placing products on the EU market. There-is-no-grandfathering. Every device must be phased into the new system and meet all new requirements that apply to it.
You will be able to download the final texts from the Official Journal website yourself in any of the 24 official EU languages that you like, but I will of course also post them on this blog as well.
You are still welcome to join our timely 10 May seminar in Amsterdam to hear more about the MDR – we expanded capacity and can host a lot more people now. We will follow up with an IVDR specific seminar soon.