Clinical Evaluation of IVD Medical Devices

Ronen E

Problem Solver
Staff member
Moderator
#11
A noob question, sorry, why is performance evaluation not expected if the device is not on the lists of Annex II
The posts above are somewhat irrelevant by now, because the IVD Regulation (came into force in 2017) mostly obsoletes the IVD Directive.

More details here.
 
Last edited:
Elsmar Forum Sponsor
#12
The posts above are somewhat irrelevant by now, because the IVD Regulation (came into force in 2017) mostly obsoletes the IVD Directive.
Thank you Ronen. Actually, I'm preparing technical files for an IVD instrument (Self-declared device under IVDD). I keep reading Annex III of IVD Directive, but still very confused if a clinical evaluation report is required by IVDD. So I searched and found this post yesterday.
Say, I obtained data from literature reviews but I can't find any guidance or basis for the report since MEDDEV 2.7.1 is not applicable.
Pardon me for these noob questions.
 

Raisin picker

Involved In Discussions
#13
Afaik, you do not need a clinical evaluation report, but a performance evaluation report, see IVDR Annex XIII (corresponding to MDR Annex XIV), and also IVDR Article 56. You might be more succesful to search for that phrase ;-)
 
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