Since the first EU Quality Management System certificate (IVDR) was issued by our notified body, TÜV SÜD, in December 2020, all relevant Quality Management Systems have been successfully audited. The respective certificates have either been handed over already or are expected to be issued shortly.
Majority of products recertified
As a result of these successful audits, already more than 50% of the notified body dependent IVDR portfolio (class B,C,D) of Roche Diagnostics have been recertified under IVDR. Declarations of Conformity (DoC) for several hundred products have been signed and in March, the first new products were launched under IVDR in the European Union (EU).
With one year left until the date of application for the new EU In Vitro Diagnostics Regulation (IVDR) Ann Costello, Head of Roche Diagnostics Solutions, comes to a very positive conclusion: “We can be very proud of our progress on the path towards the IVDR. Roche has been fully committed to this new regulation right from the beginning. And especially during these very challenging times of the pandemic, when priorities needed to be shifted, IVDR always held a top position on the list. We know how crucial it is to successfully manage this transition so our vital products will be available to healthcare professionals and ultimately patients. For the home stretch until the IVDR becomes fully applicable - and beyond - we will continue our work with full dedication.”
While the process for Roche’s own products is clear and standardized, this may vary among third party IVD suppliers. Hence Roche has reached out to all suppliers to assess their IVDR readiness as all CE IVD devices have to undergo IVDR re-certification.
Still missing regulatory infrastructure
Nonetheless, challenges remain. The additional IVDR requirements have strained the capacity of notified bodies, and important elements of the IVDR infrastructure necessary for product certifications are not yet ready. This includes EU reference laboratories required for class D certification and infrastructure for the certification of Companion Diagnostic tests. These resource constraints and infrastructure delays, which are beyond Roche’s and any other company’s control, threaten the ability of manufacturers to comply within the established timeline, which in turn could impact availability of important products for patients and customers access.
The highest criticality applies for products that were formerly self-certified under IVDD and that have been classified as class D under IVDR (e.g. SARS-CoV-2 assays). Roche remains active through industry associations and other channels to raise awareness with policy makers of the importance and impact of these issues and to seek an appropriate solution to ensure continued patient and customer access to these products.