IVDR Certification
We are pleased to announce that MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.
Of course, this is just the first step, and we are working ambitiously to certify more products under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
On our website, you can identify certified probes by the presence of the IVDR logo displayed on the left. Alternatively, you can easily filter the product list based on the regulatory status of each probe.
Open the list of all our probes with IVDR certification.
Everything Remains The Same
Our production processes have consistently met the highest quality standards in the past, guaranteeing that our products will remain unchanged during the transition from IVDD to IVDR. This saves you the time and effort of revalidations. We will continue to offer our products with the same product numbers, so there will be no changes in your ordering process. Be assured, that you can leave the time management to us, and we will always deliver IVDR-compliant products.
IVDR-Certified But Still IVDD-Labeled
Our locus-specific (XL) FISH probes are classified as Class C products within the EU, which means that, in accordance with the transitional provisions, we will only offer IVDR-certified products from 26 May 2026 at the latest.
Even though a significant portion of our portfolio is already IVDR-certified, we currently supply you with IVDD products. This is in accordance with legal requirements and is IVDR compliant. You can expect timely notification regarding the delivery of the IVDR-certified probes. We appreciate your understanding and apologize for any inconvenience this may cause.
Questions?
Please let us know if you have further questions regarding the IVDR transition, or if you would like to have an update on which probes are already IVDR-certified. Simply send an email to IVDR@metasystems-probes.com.
Related Links
- Overview of the probes that have already received IVDR certification.
- Download IVDR certificate here.