MDCG 2021-25 Applicazione dei requisiti MDR ai “legacy device”

La MDCG 2021-25 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC fornisce dei chiarimenti e delle indicazioni per l’applicazione di alcuni articoli del nuovo MDR ai legacy device conformi alla Direttiva 93/42/CEE. In allegato a questa linea guida è riportato l’Annex – table illustrating MDR requirements applicable or not applicable to ‘legacy devices’.

TESTO MDCG 2021-25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC