All stakeholders in the IVD regulatory sector have seen a steep change in IVDR transition activity since the start of 2021 as the reality hits manufacturers that there is less than 18 months to the date of application. This is fueled because some Notified Bodies have done the maths and told manufacturers to submit files by May / June 2021 if they want to sure that the review will be completed in time for 26th May 2022.
RAPS recently ran the IVDR Winter Workshop to a sell-out audience, it was great to see such an engaged audience. As part of our get to know the audience we polled the audience to take a barometer reading of where they are in their IVD journey and ask what they considered to be the main barriers to success to enable presenters to appropriately pitch their presentations. The results were as follows.
How ready are you for the IVDR?
Completed gap analysis
Prepare initial Technical File
Submitted to the Notified Body
CE marking under the IVDR
What is the greatest barrier to IVDR implementation?
The availability of qualified resources
Notified Body capacity
Time remaining until the date of application
I have been asking the same questions since I joined Qserve in August 2019, during this time we can see that manufacturers are progressing down their IVDR transition journey; however, many of them are still in the early phases. It is nice to see that some attendees have now received CE marking certificates, so the transition is underway. Some manufacturers are still waiting for their IVDR audits, which has been disrupted due to COVID. Certificates cannot be issued until an IVDR audit has been conducted, ISO 13485 alone is not sufficient.
What can manufacturers do if they are still in the planning and gap analysis phase to get up the learning curve in time?
It will become essential to get as many things as possible right first time to reduce the review time. Manufacturers will learn from their own experience; however, if you are just starting your transition process, I would recommend that you take every opportunity to learn from those who have practical experience. Attendance at the RAPS workshop and the forthcoming Convergences will provide valuable insights along with webinars run by Notified Bodies, trade associations and consultants. All stakeholders are still learning including the Notified Bodies, as their experience increases, they will have a better understanding of what they are looking for as they have increased exposure to a wider variety of files and technologies. At present we have very little IVD guidance, guidance will help understanding and consistency; however, it may also increase expectations so be prepared for change in the coming years.
Key take home message
If there is one thing you can do to help yourself along your IVDR journey and stay ahead of the curve and avoid a wipe out, I would recommend that you understand your intended purpose and how this impacts each of the pillars of your performance evaluation. This was a recurring theme from many of the speakers at the RAPS workshop, if your intended purpose is not compliant significant rework to the technical files prepared will be required, delaying and in some cases preventing the certification process. This will require discussions with your commercial colleagues and can take some time to complete.
Finally, I think all attendees would agree that time is of the essence. The Notified Bodies identified that they have capacity today but cannot guarantee that they will have it in 2-3 months’ time as that tsunami wave approaches. If you want to be sure that your products remain on the market after 26 May 2022 it is important to act now to get your technical documentation and quality system ready.