Regulatory Focus™ > News Articles > Complaint Management in the German Medical Device Industry

Complaint Management in the German Medical Device Industry

Posted 01 December 2009 | By

In Germany, there is no standardized, comprehensive law or provision for the management of complaints, customer grievances or feedback from the retail market or from the sales department regarding medical products (complaint management). The procedure for handling actual occurrences is covered by the regulations of the German Medical Devices Act (MPG) and the German Ordinance on the Recognition, Assessment and Avoidance of Risks Posed by Medical Devices (MPSV). However, the broader question of how a company needs to be organized in order to be able to gather market information and put it to the proper use is not covered by these regulations, either.1 This in spite of the lack of guidance is surprising, given that the organization of complaint management and the way in which the data obtained are dealt with are as much a part of a company's obligations as other issues falling under the term "compliance." This article offers an overview of the current legal and normative requirements and framework and develops a structural concept for complaint management.

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