Software Guidances for MDR and IVDR

The EU Commission has issued guidance documents for Medical Device Software within the scope the EU 2017/745 MDR and EU 2017/746 IVDR. The first publishment related with MDSW is MDCG 2019-11, contains information on the qualification and classification of¬†medical device software. The second one is MDCG 2019-16 which is a guidance document on Cybersecurity for … Read more

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 … Read more