An interesting revision of the Guidance MDCG 2021-6 has been published that includes several new questions covering topics such as the conduct of combining 2 different study designs in the same CIP, the conduct of clinical investigations for combination products, required submission documents, considerations for usability testing, the role and responsibilities of a sponsor’s legal representative, etc.
The update of the previous questions provides clarifications on the available regulatory pathways depending on the developmental stage of a medical device and the definition/notification of substantial modifications.
Questions 48-50 provide some clarity on the responsibilities of the legal representatives.
Evnia has summarized the new elements of the Guidance here: MDCG 2021-6 REV.1.
Full text of the Guidance here
If you more clarifications or are considering MDR IVDR training for your team, do not hesitate to contact us!
