PARAMETERS FOR CLASSIFICATION OF MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC MEDI ...

PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic princi ...

7.2 Bio-compatibility: (i) The dossier should contain a list of all materials in dire ...

(b) the intended user (lay person or professional); (c) a general description of the ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

2. Personnel: (i) organisation chart showing the arrangements for key personnel; (ii) ...

7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

(b) conformity with an in-house test method; (c) the evaluation of pre-clinical and c ...