As the song appropriately sung by the band Europe said, “It’s the final Countdown”. We have one year to go before the date of application, so what is the state of play?
Are manufacturers ready?
The situation is improving but from data we gathered in February only 11% of a RAPS audience had submitted to a notified body, as this is effectively a pre-selected audience of regulatory professionals, so we can assume this is the best case scenario as they were already aware of the regulation and attending training. Notified bodies expect the crest of the IVDR tsunami to break in July 2021.
What keeps you awake at night?
I often ask this question as a way of focusing the most critical issues. What industry tells us in the time to the date of application and notified body capacity are their primary concerns. Many manufacturers who have submitted their first files have many more to submit so whilst they are at the front of the pack, they still have real concerns about keeping product on market and many are looking at options to build stock in the distribution chain in Europe to ensure continuity of supply to customers whilst remaining files are processed. In addition access to suitable trained resources is key for all stakeholders and everyone is looking for the same resource.
The elephant in the room, will there be a delay?
Many were hoping that there would be a delay for all devices similar to the MDR; however, the COVID pandemic demonstrated that the IVDD classification was not fit for purpose as there was no third-party oversight for these high-risk tests. The old adage, plan for the worst and hope for the best applies, personally I would not assume that there will be an extension and continue to drive for the line. Common sense does suggest something has to give, but it may not be for your device. If there is an extension; don’t waste it! We still see manufacturers struggling to meet the MDR when they have had a one-year extension and since notified body approvals could take 9-11 months to process you still need to be ready as soon as possible.
Make sure that your intended purpose meets the requirement of the IVDR and that your broader claims and supporting data in the performance evaluation are consistent and support this, intended purpose remains a key source of notified body findings. The IVDR is precise and prescriptive, pay attention to detail, if the IVDR requires a report you need to provide one unless you can justify why it is not applicable.
There are many implementation issues, some are created due to a lack of infra-structure such as Reference Labs and Common Specifications, others are issues that only came to light once the legislation is used in practice. For example; performance evaluation studies started under the IVDD Annex VIII but will not be completed till after the date of application.
Some of these issues will be helped by the publication of guidance; however, if we look at the experience from the medical device field publication or MDCG guidance can also sometimes increase expectations. It will be very important to track the publication of the MDCG IVDR Performance Evaluation guidance, this has been circulated for comments and due for publication in 2021. It is also important to remember that once these documents have been published there should be a process of remediation for existing files as this will be the new gold standard when files are sampled.
Distance sales is also a new feature of the IVDR so the MDCG guidance documents on Qualification of assays used in clinical trials of medicinal products and another on In-house devices will be important to labs who are currently providing clinical lab developed tests to the EU market. These documents are also due in 2021.
Transition to the IVDR is definitely a huge mountain to climb; however, it is important to remember that the effort to maintain products on market is significantly more that expected under the IVDD. There will be notified body audits, sampling reviews, unannounced audits and the release of new guidance which must be remediated in all files.
New regulatory oversight conformity assessment processes will increase time to market for devices entering the EU market and as a result it may no longer be the most efficient practice to enter the EU market before the US for example, as a result wider market access strategies may need to be re-engineered.
Now that we are entering into the final countdown it focuses minds, that the IVDR is really happening. It is rather like climbing to the top of a rollercoaster ride, we can see the track ahead, we can see the twists and turns but we can’t stop moving forwards; so it’s time to hold on tight and do the best we can to be ready for 22 May 2022.