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NBOG's Best Practice Guide NBOG_BPG_2009_4 (July 2009) INTRODUCTION The Directive 93/42/EEC concerning medical devices (MDD) contains possible conformity assessment procedures in order to CE mark devices. Up to now, there has been inconsistency in the way Notified Bodies (NB) have performed the assessment of technical documentations for Class lla and Class llb products following quality system conformity assessment routes. The Directive 2007/47/EC, covering the revision of the MDD, includes additional requirements for review of technical documentation for all Class IIa and Class IIb medical devices covered by quality system assessment routes. SCOPE This guideline has been prepared for NBs on how to assess the technical documentation on a representative basis according to the Directive 2007/47/EC. Attention was given to the sampling size and depth of the assessment. It will also be useful for Designating Authorities in monitoring the performance of their NBs in this area. The Guidance is available in our library. Or may be downloaded directly here: NBOG_BPG_2009_4 Source: www.nbog.eu |
