Stay ahead of the game, do not leave it for later...

The EU IVDR deadline transition period is on. Get your documentation ready now and do not wait until the last minute!

Our compliance experts have put together this White Paper to help you, your business, and your official documentation to successfully transition to the IVDR regulations

In May 2017, it was announced that the Medical Device Directive (MDD), the In Vitro Diagnostic Medical Devices Directive (IVDD), and the Active Implantable Medical Device Directive (AIMD) — would be replaced by new MDR and IVDR standards in order to improve clinical safety for patients and users, standardise and harmonise information, and provide a level playing field for both healthcare professionals and manufacturers.

The MDR came into force in May 2021, and it will shortly be the turn of the In Vitro Diagnostic Regulation (IVDR) 2017/746, the new EU legislation applicable to in vitro diagnostic (IVD) medical devices that replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC. The new IVDR regulation, which affects the manufacturers of these devices and any party involved in the supply chain or providing related services, will become mandatory as of 26 May 2022. However, the length of the new proposed transition periods now depends on the type of device, establishing a transition period until May 2025 and 2026 for high-risk devices like HIV and hepatitis tests, allowing until May 2027 for lower risk class B and A sterile devices.

Under the IVDR, IVD device manufacturers wishing to place their products on the European market, are required to:

obtain a CE mark to prove they are compliant with the new rules
define the class of every device
implement a quality system
designate a notified body to audit all relevant documentation.

This final aspect implies important imperatives in terms of the language of the documentation, including the labelling and the instructions on how to use the devices.