Description
Date of publication: May 2019 (updated in March 2022)
115,00€ excl. VAT
IVDR poses obligations on manufacturers and makes the regulatory framework more stringent for IVD manufacturing process. However, some temporary derogations are envisaged for manufacturers that may apply depending on the date of issue of the CE certificate. This guidance provides information on how to strategically plan the transition to IVDR.
Date of publication: May 2019 (updated in March 2022)