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MDCG publishes new guidance on transitional provisions for MDR consultations

  • Posted by: inetika
  • Category: GLOBAL NEWS

The European Medical Devices Coordination Group (MDCG) has just published a new guidance document titled ‘Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues’ (MDCG 2020-12).

The intent of the guidance is to identify differences between the Medical Device Regulation (MDR, 2017/745) and the preceding device directives (MDD, 93/42/EEC and AIMDD, 90/385/EC) and clarify how manufacturers of legacy devices of these types should address any new requirements.