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 medical devices. The main purpose of this document is to provide manufacturers with guidance on how to fulfil all the relevant essential requirements of Annex I to the MDR and IVDR with regard to cybersecurity.
And the last one is MDCG 2020-1 which is a guidance document on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software. The purpose of this guidance is to provide a framework for the determination of the appropriate level of Clinical Evidence required for MDSW to fulfil the requirements set out in EU 2017/745 MDR and EU 2017/746 IVDR. This guidance should be applied to MDSW.
Software developers should refer to MDCG 2019-11 for guidance on the appropriate qualification and classification of software and MDCG 2020-1 for Clinical Evaluation (MDR) / Performance Evaluation (IVDR) apply to all MDSW prior to such software being introduced into the market.
If you need further information about your medical device software, do not hesitate to contact us. Our experts will be happy to help you.