MDCG revises guidance on application of MDR to ‘legacy devices’

Article summary

The Medical Device Coordination Group (MDCG) has amended its guidance on the application of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021. The revision ensures the guidance aligns with the general structure of other MDCG guidance documents and takes into account Regulation (EU) 2023/607, which amends the MDR and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The updated guidance confirms that Article 19 of the MDR does not apply to legacy devices, and provides clarification on the application of the transitional provisions to systems and procedure packs covered by a declaration drawn up pursuant to Article 12(2) of Directive 93/42/EEC (the Medical Devices Directive), as well as regarding the requirement to put in place a quality management system in accordance with Article 10(9)...