MDCG 2019-10 Article 120 Guidance

The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published. Article 120 defines the requirements  for 93/42 / EEC MDD certificates to be valid after May 26, 2020.

The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates can be summarized as;

  • No significant changes on the device design
  • Implementation of the main requirements related to post-market surveillance, market surveillance, vigilance, registration of economic operator

You can download the guidance on MDCG 2019-10 from this link..

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