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Andre von Muller
Consultant, Regulatory Affairs, FDA, Manufacturing
Carefusion
Yorba Linda CA
United States
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YES - Additionally BSI will look for the following: (applicable to Technical Files)
1.- Compliance with MEDDEV 2.7.1, Rev. 3 (or latest) Guidance on Medical Devices,
2.- Compliance with amendment M5 of the MDD Council Directive 93/42/EEC (this is for the entire Technical File),
3.- Clinical evaluations need to have a section outlining the qualifications of the author.
NOTE: Usually a brief bios or CV (curriculum vitae) of the author is enough. If the Scientific Literature evaluation or Clinical Review is not performed by a Clinician (who are actually the most qualified personnel to write or perform this type of evaluation), then it helps to have the clinical evaluation (a.k.a. White Paper) countersigned by a Clinician or someone that has the qualifications to write a clinical Evaluation.
NOTE: Make sure your claims or clinical results or summaries are also captured in your ER (Essential Requirements) checklist. Otherwise there is a gap or inconsistency of results presented.
A couple of months ago, we had a three-day audit only on Technical Files (a.k.a. Dossiers), and ended up with a couple of minor findings (such as lack of CV or qualifications of the author who performed th Clinical Evaluation), and lack of a rationale for NOT using the Machine Directive 2006-42-EC, and also for not using Personal Protective Equipment Directive 89-686-EEC. (BSI Checklist)
Hope this helps
Original Message:
Sent: 08-11-2011 08:29
From: Julie Powell
Subject: technical file review (CE)
Yes - Notified Bodies are either scheduling additional time on site or requesting Technical Files to be submitted for off site review, prior to the on site audits. We are seeing increased focus on (1)Clinical Evaluation Reports, (2) Risk Analysis and (3) Post Market Surveillance and verifying that completed in accordance with MDD, guidance documents and standards, as applicable for the area.
Best of Luck,
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Julie Powell
Emergo Group
Delton MI
United States
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