If you have questions about what the MDR will mean for your company and happen to be in San Jose in California on 25 September, consider attending the evening workshop that Factory (the Dutch devices CRO) and I are organizing on Monday, 25 September 2017 from 19:30 to 21:30 (PDT). You may be in San Jose anyway for the Advamed MedTech conference so this is a nice opportunity to get a more detailed perspective on the MDR and IVDR.

As I am writing this I’m at the RAPS Regulatory Convergence conference in Washington DC (another nice opportunity to educate yourself on the EU MDR and IVDR by the way), finding that way too many US companies have no idea what the new EU regulations will mean for their company and how to implement them. And implement them you must because the regulations will not provide for grandfathering. Just not – so not being compliant by 25 May 2020 means (subject to some very limited and inconvenient exceptions) no more placing additional products on the EU market, even if you have been selling into the EU for decades without any incident ever. Timely compliance is a must and while already 1/9 of the transitional period has expired by now, so if you haven’t started by now you are not in a good place. Read up on how to and timelines here.

The workshop will specifically focus on the new clinical evidence requirements but it will give you a great opportunity to ask any other questions that you may have about the new MDR (or IVDR) requirements and how to transition to compliance. It’s exciting for me too  because it’s the first ever US event I’m organising.

Because we need to rent a location we are asking a small nominal contribution to pay for location and snacks/drinks. Space is limited unfortunately and so are the tickets (we have a 100 available so be quick) – purchase yours here.

Program:

• 19:30        Major changes in Clinical Evidence for CE marking: MDR/MEDDEV Rev 4.
• 20:00        Clinical Evaluation Reports under the new regulations
• 20:30        Clinical Investigations and Post Market Clinical Follow-up
• 21:00        How to close the gap towards the MDR: legal and practical perspectives

Hope to see you then and there!