Key highlights include:

🔹 Aims to present information about the design, conduct, analysis, and results of the clinical investigation in easily understandable terms for the intended user.

🔹 Report and its summary should be submitted to Member States via an electronic system.

🔹 Summary should be free from promotional content and consider users' levels of health literacy and numeracy.

🔹 Summary includes components such as title of investigation, purpose, description of investigation and methods used, results, and conclusion.

🔹 Cover page should include details like the date, title of investigation, sponsor and funding entity contact details, and single identification number.

🔹 In-depth content structuring is provided, including brief study title, description of the design, experimental medical device, comparator, care provider, dates of investigation, location, purpose, and detailed description of the device, investigation, methods, and study design.

🔹 Summaries will be publicly accessible at the latest when the device is registered and before it is placed on the market

🔗 Original Document :  https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52023XC0508(01)