The annual MedTech Summit was held this year in Brussels. The IVD stream provides 2 days of focused content relevent to the IVD Industry, strongly focusing on the EU IVDR. I was fortunate to present a session on Intended Purpose under the IVDR, something that is very critical to the transition to IVDR. Anyone who has listened to me present previously knows that I strongly recommend a good, early understanding of the Intended Purpose of the device.
In an attempt to summarise the discussions over the last 2 days, I have three main take away messages:
See IVDR as a positive opportunity
Since the IVDR was first published, the industry had widespread concern with the problems the industry would face to get ready for the higher compliance. Delays in infrastructure, including a slower update of Notified Bodies to support the process, resulted in additional transitional timelines for class B, C and D devices.
Feedback from a number of Notified Bodies now suggest that they are all open for new applications, and they have the resource to support manufacturers for conformity assessments. It is the manufacturers themselves who are not ready for the application process. While it is understandable that external political, economic and practical factors are delaying manufacturers readiness to IVDR, there is no better time to push forward with the process. While some elements still need to be addressed (EUDAMED, EURLs), on the whole, the industry has enough knowledge, guidance and resource to successfully implement IVDR.
So if you haven’t started, don’t delay, start the process! You can get through it. NBs have the time and capacity (for now) to support you through the process. We know that this capacity will be taken up from 2024 as we get nearer the deadlines: so get ahead of the crowd – there is no better time to make a start!
Make the best effort you can on your technical documentation
All devices will need to have an new or updated series of technical documentation to be ready for IVDR, irrespective of class. From the discussions, the message is clear. Closely follow Annex I, II, III and guidance provided by the NBs as best you can. Really take on board the principles of Clear, Organised, Unambiguous, and Readily Searchable when building your documents.
There is a correlation between the time and effort building your technical documentation, including your analytical and clinical data, and the successful outcome and time taken for the conformity assessment. The better you prepare the higher a chance of success.
Make UKCA work for your business goals
Hopefully you will have seen the update from the MHRA on the timelines for UKCA marking. More will be coming in the months ahead as we gear up to the new MDR2002 (UKCA). However, up until June 2025, manufacturers placing new devices on the UK market can benefit from the existing MDR requirements based on the IVDD. The majority of devices remain self-declared (except high risk devices, and self-tests), so while you still need to meet the safety and performance requirements of the UK regulation, this remains a quicker and cheaper route to market compared to the EU, FDA (and UK beyond 2025). Once your devices are placed on market, you will have 5 years to build up your QMS and Technical Documentation to meet the new UKCA requirements.
For SMEs especially, this would allow devices to be on market, producing revenue quicker, and in an important market, while you continue to develop and grow your regulatory compliance. But you don’t have long, now is the time to start this process!
Overall, being at events like MedTech Summit, it reminds me how great our industry is. The effort, positivity and willingness to make a better healthcare system for patients is truly remarkable, keep up the great work people, we can and will overcome!!
For further information or further insights on UKCA or IVDR, or how IVDeology can help you with your regulatory goals, please contact [email protected] to book a call with me.