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Device classification guidance now updated for MDR

  • Posted by: inetika
  • Category: GLOBAL NEWS

The EC Medical Device Coordination Group (MDCG) has now published its guidance reference MDCG 2021-24, ‘Guidance on classification of medical devices’, to help manufacturers of devices regulated by the Medical Device Regulation (MDR, 2017/745) reach the correct conclusion about specific devices.

The guidance follows the same format used for the preceding guidance relating to the classification rules of the Medical Device Directive (MDD, 93/42/EEC), resulting in a 57-page document that again includes flow charts and tables.

Copies of the guidance can be downloaded from here.