An NSF International Company The Qualified Person In The New European Regulation
Tuesday the 3rd December 2013
This brief article outlines the new EU requirement for a “Qualified Person” (QP) which is contained in the EU Regulation due to replace the current medical devices Directives 93/42/EEC and 90/385/EEC. The new Regulation has been the subject of fierce debate between the various stakeholders throughout the EU, and there may be many more changes before final agreement is reached. However, the requirement for manufacturers to have a Qualified Person appears to be generally accepted and is virtually certain be included in the final Regulation.
In fact, even before the new Regulation is eventually implemented, Notified Bodies will be looking at the competency of manufacturers’ key staff with renewed vigour. No one wants a repeat of the fiasco at PIP (reported by the BBC at http://www.bbc.co.uk/news/) where key staff were found to be respectively a cook and a pastry chef.
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