At Advamed’s San Jose MedTech Conference this year it was quite a surprise for me to see how many US companies are still not doing what is necessary to become compliant with the MDR and the IVDR in time. In the EU MDR session at that conference about 5% of the audience raised their hand to the question what companies had a transition plan for these new regulations that they expected to finish in time before the end of the transition period.
This means that the rest of the companies represented do not expect to be ready in time, which is a problem since the MDR (and IVDR too) does not grandfather any products currently on the market. Companies just do not seem to understand this – every device currently on the market has to be CE marked again under the new rules. That’s a very big project, with very much at stake: essentially your European market as of June 2020 for medical devices and as of June 2022 for IVDs. We in the EU MDR session panel were stunned by this level of unpreparedness on the part of US medtech companies so I decided I wanted to do my best to remedy this.
How to make the transition and stay in the market?
I’m very proud and happy to announce that Advamed has decided to organize an MDR and IVDR workshop at the Advamed offices in Washington DC on 4 December – quite soon already – which is called “The new EU Medical Devices and IVD Regulations: How to make the transition and stay in the EU market?”.
It’s a day-long workshop in which I will help your company make sense of the MDR and IVDR, define its transition goals and strategy, perform a gap assessment and come out compliant in time before the end of the transitional periods. It will be practical and there will be a lot of opportunity to ask questions. Also, I wil discuss how to develop your template documentation for a gap assessment and transition plan, provide starting material for that and discuss what moving parts to pay attention to as the EU is rolling out the MDR and IVDR.
Sounds good? You can register here. I promise you it won’t be boring – hope to see many of you then and there!