Our Products are IVDR-Certified!
We have successfully obtained our certification under the new In Vitro Diagnostic Regulation (IVDR; 2017/746)! Very soon, the first batch of flagship products will be available on the market under the new IVDR, well in advance of the transition period deadline. This important milestone is the culmination of the collective hard work and dedication of everyone at MRC Holland over the past few years and we are proud to have achieved it!
What is new in the IVDR?
The IVDR, which came into effect in May 2022, thereby replacing the previous directive (IVDD), is a more comprehensive regulation that introduces a more stringent framework for IVD devices and a new risk-based classification scheme. Under the IVDR, 80% of all IVD devices are subject to an independent review by a notified body and manufacturers need to provide much more in-depth data to substantiate their safety and performance claims.
What does it mean for MRC Holland and our customers?
Receiving the IVDR certification demonstrates our long-standing commitment to providing accessible genetic testing with assays that meet the highest quality and safety standards. The transition from the IVDD to the IVDR will happen gradually with our first batch of 14 products transitioning already in January 2025. Stay tuned for regular updates in our newsletter, on LinkedIn, and on our website as we add new products to our IVDR certificate.
To align with the heightened standards of the IVDR, we will be adjusting the Intended Purpose of some of our products, thereby ensuring they meet the highest regulatory requirements. We will keep all relevant users informed of product additions to the expanding IVDR certificate as well as any potential changes to their intended purpose. The relevant product pages will also be updated to reflect these adjustments.
Which products are available under the IVDR?
Currently we offer the following products under the IVDR certification:
In the upcoming time we will make more products available on the market under the new IVDR. We will add these products to this news article as soon as they are available as such.
MLPA products that are available under the new IVDR will also have an updated product description in a new structure and layout. The new format is easier to read, maintain and translate.
More information about the changes to the product description can be read in this article.