Medical device CE marking

2 new MDCG documents issued: MDCG 2022-17 and MDCG 2022-18

2022-12

The MDCG has issued 2 new documents:

  • MDCG 2022-18 – MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – 9 December 2022
  • MDCG 2022-17 – MDCG position paper on ‘hybrid audits’ –  6 December 2022

The documents can be downloaded in our library: MDCG 2022-18 and MDCG 2022-17

Source: European Commission