Fact Sheets

MDR adherence | MDCG guidance for Clinical Affairs

Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process, we have compiled a useful summary of all the relevant MDCG guidance regarding MDR adherence relating to clinical investigations, clinical evaluation and clinical data, within an easy-to-read fact sheet.

The guidance we’ve collated spans 2019 to 2021. Some of the guidance documents focus on interpreting MDR, whilst others provide templates and detailed processes for action to be taken. All are helpful in terms of harmonization between Notified Bodies, Competent Authorities and manufacturers regarding MDR implementation in the Clinical field. You can access the fact sheet by clicking the Download button below.