The 26th of May 2022, the application date of the EU IVD Regulation 2017/746 (IVDR), marks a farewell to the medical device Directives. This long farewell has already lasted several years, and after the application date, placing devices on the EU markets under the Directives will still be possible in certain circumstances. However, due to this historic transition to the In Vitro Diagnostic Regulation (EU IVDR), the entire IVD medical device field will be highly impacted. All interested parties, including the European Commission, the competent authorities, the notified bodies, the manufacturers and the supply chain have had their share of the new requirements. The reclassification of the IVD devices together with the new roles recognised by the IVDR means busy times for everyone in the field in the up-coming years.
Why do we need this historic change? The main reason for the legislative change, as defined by the European Commission, is to ensure a robust, transparent and sustainable regulatory framework and to maintain a high level of safety while supporting innovation in the EU. The IVD Directive 98/79/EC was published in the 90’s, so it is evident that a new regulation is urgently needed to align with this fast-evolving field. Over the last decades, the development of health technologies has been incredibly rapid. For example in DNA sequencing – a technique frequently utilised in the IVD field – tremendous progress has been made in terms of speed, read length, and throughput. This has enabled sequencing of the whole genome and using DNA sequencing techniques to diagnose disorders or to plan personalised medicine aimed for cancer treatment.
The new Regulation is much needed, but will it support innovation? Time will tell, but for now it seems that we are facing several challenges due to the new requirements, as the regulatory infrastructure is not ready yet. There are several elements, such as the EUDAMED-database, the expert panels, the reference laboratories and the guidance documents, that would be urgently needed but are not yet ready or published.
And did I already mention the notified body situation? Currently, there are 7 IVDR notified bodies listed in the NANDO database (and presumably 1–2 more to be added this year) that will be able to perform conformity assessments under the IVDR. This is far from sufficient to deal with the conformity assessment activities for all the risk class As, B, C and D device manufacturers. In addition, the device reclassification impacts the notified bodies working in the IVD field, as the competence requirements to perform assessment activities have significantly extended as compared to the notified bodies working under the IVD Directive.
The IVD medical device manufacturers cannot place class As, B, C or D devices on the markets under the IVDR before a notified body conformity assessment has been completed. And with only 7 competent notified bodies available, this can lead to a serious disruption of the supply of essential healthcare products to the EU markets.
To avoid this situation, the European Commission proposed in October 2021 a progressive roll-out of the Regulation and published an amending regulation (EU) 2022/112 providing additional transition time for the class As, B, C and D devices. Read more about the transition times in the DRA news published earlier this year.
Although additional transition time has been allowed for the IVD manufacturers, it is time to act now to make sure that you are well prepared. The changes to be made to the quality management system, to the product documentation and to the supply chain control require an extensive amount of work and resources. In addition, there is considerable uncertainty about the approval process, as the regulatory infrastructure is not fully in place.
It is highly important that we work together to ensure the availability of the IVD healthcare products on the EU markets also in the up-coming years! If you need support or additional resources to tackle the IVDR challenges, please contact DRA’s Heath Tech team! We are here to help you!
A FEW KEY TIPS FOR THE IVD MEDICAL DEVICE MANUFACTURERS:
- Check the availability of a notified body that can assess all the products in your portfolio.
- Verify that you have recognised all the economical roles applicable to your company. Pay attention to the supply chain oversight!
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