mdcg

Use of Harmonised Standards: MDCG 2021-5

Use of Harmonised Standards The MDCG 2021-5 Guidance on standardisation for medical devices explains the use of harmonised standards for demonstrating compliance to MDR (EU 2017/745 ) and IVDR (EU 2017/746) . Although this guidance document does not include new information, it is especially helpful for medical device start-ups and manufacturers, which are at the …

MDCG 2019-10 Article 120 Guidance

MDR Transitional Period 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.  The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as; The guidance includes a paragraph about the surveillance …