Post Market Surveillance SOP
Post Market Surveillance SOP
1. General
1.1 This document is intended to indicate a high level system approach with respect
Annex X, to Post Market Surveillance activities for <company> products, services and
1.1c quality systems.
1.2 <company> has various procedures, templates, forms and databases etc in
8.2.1 place to monitor devices in the market, post sales. As indicated in MDD
paragrap 93/42/EEC and various quality standards, monitoring the product (and related
h4 service provision) do not end at the production release stage.
1.3 It is not intended to be totally inclusive of every document (and any other
source, including anecdotal evidence) used for feedback purposes; as these are
mainly referenced in the appropriate procedures (see below). Since this is an
overview, there will still be an element of duplication with existing procedures.
However, this procedure is intended to reinforce the fact that an overall Post
Market Surveillance (feedback) system is clearly in place.
1.4 There are also various other recognised external guidance documents that can
assist the feedback system1, 2, 3.
2. Relevant Procedures
References
1. Guidelines on Post Market Clinical Follow-Up; MEDDEV 2.12-2; May 2004
2. GHTF; Clinical Evaluation; SG5/N2R8:2007
3. Guidelines on Medical Device Vigilance System; MEDDEV 2.12-1 rev 5; April 2007
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