EU: Draft of second corrigendum for the MDR published

The EU has published a draft of a second corrigendum relating to EU Regulation on Medical Devices 2017/745. Alongside minor corrections of references and spelling mistakes, it also implements changes to Article 120 on the transitional provisions. The change enables manufacturers of Class I products in accordance with Directive 93/42/EEC, which require the involvement of a notified body for the conformity assessment as per the regulation, to place these on the market until May 2024 using the existing declaration of conformity. The corrigendum is not yet legally binding.

Go back