The entry into force and implementation of Regulations (EU) 2017/745 and 2017/746 were marked by the introduction of high and strict requirements, the main objective of which is to guarantee and strengthen the safety and effectiveness of devices marketed within the European Union. In this context, the activities carried out by Notified Bodies (NBs) as part of surveillance activities and post certification monitoring have been considerably strengthened, in particular with the requirement for NBs to carry out periodic unannounced audits at the premises of manufacturers or their subcontractors.
This newsletter presents the main regulatory requirements relating to unannounced audits, specifies how they are to be carried out, and provides recommendations to ensure that they run smoothly.
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