Changes for qualification of IVD software and intended purpose.
Updated as a result of the end of the Brexit transition period.
New version published with updated information on clinical calculators, clarification on interpretation of direct diagnosis, addition of new indicative words, IVF products for selection of blastocysts, ECJ Case C 329/16 and Control of Conception.
Uploaded a new version of the guidance. This includes a new appendix on symptom checkers, and edits to the introduction (page 4), diagnosis (page 19) and new links related to GDPR.
Document updated with link to new Introductory Guide to new medical device regulations.
Updated guidance in attached document.
Updated software guidance. Minor changes and clarification.
We have updated the format of the guidance. It is now an interactive PDF.