Second corrigenda to the MDR and IVDR published

The EU Commission has now published the second corrigendum to the MDR and the second corrigendum to the IVDR in the Official Journal of the EU (OJEU).

The key change to the MDR states that devices classified as Class I under the MDD can continue to be placed on the market until the 26 May 2024 if the following conditions are met:

  • The manufacturer has issued a ‘Declaration of Conformity’ under the MDD prior to 26 May 2020

  • The devices require notified body involvement under the MDR

  • There are no significant changes in the design or intended purpose of the devices after the 26 May 2020.

EPSL Regulatory Consulting
Legal Privacy All content © ESPL Regulatory Consulting
Registered Office: 71-75 Shelton Street, Covent Garden, London, United Kingdom, WC2H 9JQ
Website by Denvir