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MRC Holland is dedicated to ensuring our products align with the latest European In Vitro Diagnostic Regulation (IVDR). Here is a brief overview of our progress.
The In Vitro Diagnostic Regulation (EU) 2017/746, commonly known as IVDR, represents a significant improvement in the regulation of in vitro diagnostic medical devices (IVDs) within the European Union. Enforced since May 26, 2022, the IVDR aims to elevate the safety and efficacy standards of IVDs available on the EU market. In comparison to its predecessor, the In Vitro Diagnostic Directive (IVDD), the IVDR introduces a more rigorous framework, emphasizing performance studies and post-market surveillance.
The shift from the IVDD to the IVDR is accompanied by a transitional period with a staggered end date based on the risk class of the medical device. MRC Holland's extensive product range, including SALSA® MLPA® probemixes, Coffalyser.Net™ analysis software, and SALSA® MC002 SMA Newborn Screen, currently complies with the IVDD requirements. As part of the transition period, MRC Holland products can remain CE-marked under the IVDD until May 2026.
To maintain our commitment to provide products for in vitro diagnostic use in European labs, we are well on track to meet the IVDR standards before the May 2026 deadline. Annual audits conducted by our notified body confirm the compliance of our existing Quality Management System with the IVDR. Furthermore, we are pleased to share that the first MLPA probemix SALSA® MLPA® Probemix P051 Parkinson mix 1 and Coffalyser.Net analysis software were positively assessed for IVDR compliance by our notified body, with several other products currently being under review, marking a crucial milestone.
For MLPA probemixes, our ability to demonstrate compliance with the IVDR by conducting additional performance evaluation studies depends on the availability of positive DNA samples. These samples, often for rare conditions, are not always readily available to MRC Holland. We therefore invite clinical laboratories to collaborate with us, so that we can keep MLPA products available as IVD assays. See the "Wanted: DNA Samples" news item for more information on the specific samples we are currently looking for.
For additional information on this topic or other specific inquiries, we encourage you to reach out to our Regulatory Affairs department at RA@mrcholland.com. You can indicate your wish to receive news about the changes in the regulatory status of your favourite product by using your personal MRC Holland account