"Back in October 2021, we wrote a blog with the tagline '
Don’t take your foot off the gas!', this seemed to hit a chord with many stakeholders and I’ve heard us quoted at several conferences," Sue Spencer, Head of IVD.
We are now on the eve of the IVDR date of application, so has anything changed?Notified Bodies are still overloaded and the infrastructure such as EUDAMED plus processes for Class D and CDx devices are still evolving. If you have a technical file that is in a good shape and fully IVDR ready it will still take 6-9 months to progress through the NB and at least 18 months for a CDx, if you have managed to gain a place in the queue.
This is why you cannot afford to take your foot off the gas! You will need the full extension period just to complete the conformity assessment.
Are you ready for the new IVDR?Whilst there is an extension to the transitional arrangements for Class A sterile, B, C, and D devices. Class A non-sterile devices must meet the IVDR by 26 May 2022, this includes extraction kits, accessories, and instruments.
Don’t forget that for all products companies should update their Quality Management Systems including post-market surveillance requirements and vigilance to the IVDR by 26 May 2022. All new products and any product that undergoes a significant change after this date must meet the requirements of the IVDR including conformity assessment by an NB before it can be placed on the market. The
significant change guidance MDCG 2022-6 has just been published.
The
IVDR requirements are detailed and more complex, and it will take longer to prepare files than it did in the past, longer to get certification, and will require more resources to maintain.
Implementing the IVDR The new additional transitional arrangements provide extra time for conformity assessments to take place, this is required whilst the IVDR infrastructure is being implemented and to ensure the availability of in vitro diagnostics on the EU market, but this does not apply for all devices.
What should you prioritise? Companies have to revise implementation plans. The priority has been switched to those devices that do not benefit from the
transitional arrangements, for example Class A accessories such as wash buffers and instruments. Class A devices may be lower risk but they still take time to prepare.
Updates to the Joint Implementation and preparedness Plan for IVDRAn update to this joint plan was released on the 1st of April 2022, just after its February update. The latest update includes the addition of two new “high priority” areas to address legacy devices and EUDAMED and 2 new action items added. Read the
blog by Christie Hughes.
At Qserve we have been working with customers for the last 3 years to gain compliance, this includes companies from start-ups to multinationals working with most of the IVDR designated NBs, as a result we have helped these companies to successfully CE mark.
Are you struggling with the transition?
All stakeholders are learning, guidance documents are evolving and the IVD sector is now learning by doing. Qserve can support the transition at all points on your journey from your IVD devices to the new IVDR and help you with practical implementation issues and share best practices. Do you want to know what our team could do for you?
Contact our dedicated IVD team.
