AUDITS AND ASSESMENTS PERFORMED BY NOTIFIED BODIES IN THE FIELD OF MEDICAL DEVICES - UNANNOUNCED AUDITS
(For unannounced aduits see annex III) COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (Text with EEA relevance) (2013/473/EU) ...omississ... HAS ADOPTED THIS RECOMMENDATION: 1. PURPOSE To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC, the notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits. By providing general guidelines for such assessments and unannounced audits, this Recommendation should facilitate the work of the notified bodies as well as the Member States’ evaluation thereof. This Recommendation does not create any new rights and obligations. The legal requirements applicable to all types of devices and conformity assessments are set out...