Brussels – 24 September 2013
Today, the European Commission published a recommendation on the audits and assessments performed by notified bodies in the field of medical devices. The Recommendation provides general guidelines for product assessments, quality system assessments and unannounced audits. The guidelines do not include new rights or obligations, but aim to ensure that notified bodies carry out a proper verification of the fulfilment of the legal requirements by the manufacturer.
In the Recommendation the European Commission outlines what it expects from assessments, as well as unannounced visits of Notified Bodies to manufacturers. The Recommendation applies to the conformity assessment of medical devices, active implantable medical devices and in vitro diagnostics covered by Directives 93/42/EEC, 90/385/EEC, and 98/79/EC.
The text of the Recommendation can be found here, and will be available in our Library shortly.
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