The Commission of the European Union (EU) has amended key transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746 (also known as the IVDR), in an effort to ensure the supply of qualified devices during the COVID-19 pandemic.
Published in the Official Journal of the European Union, Regulation (EU) 2022/112 extends for one year the date by which existing in vitro devices that have been reviewed and certified by an EU Notified Body in accordance with the provisions of EU Directive 98/79/EC must comply with the requirements of the IVDR. Manufacturers of these in vitro devices now have until May 27, 2025 to achieve compliance with the updated requirements.
In addition, most in vitro devices that do not require an assessment by a Notified Body will have even more time to bring their devices into compliance with the requirements of the IVDR. Manufacturers of Class C devices will have until the end of May 2026 to affirm compliance with the IVDR, while Class B and Class A devices will have until the end of May 2027.