IVDR readiness statement
The new In-Vitro Diagnostic Regulation (2017/746/EU) replaces the current In-Vitro Diagnostic Directive (IVDD 98/79/ec) after a five-year transitional period, which ends on 26 May 2022.
It provides the regulatory framework for safe and effective tests for the benefit of patients.
We have long been determined to ensure the present and future availability of our products under the new European medical device rules. Our intention is to fulfil IVDR requirements for our IVD products until the end of the transition period, to meet the needs of our customers by ensuring the continuous supply of essential, system-relevant in-vitro diagnostic medical devices.
Questions? Please contact IVDR.