I have a doubt on PMCF, and more specifically on Annex XIV, Part B 6.2.(a) vs. 6.2(b) and the notion of general methods vs. specific methods.
The PMCF plan shall include at least:
(a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
(c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
Are "general methods" of PMCF (gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data, etc.) the same as PMS ?
The PMCF plan shall include at least:
(a) the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data;
(b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies;
(c) a rationale for the appropriateness of the methods and procedures referred to in points (a) and (b);
Are "general methods" of PMCF (gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data, etc.) the same as PMS ?
