Visio-Classes of Medical Devices - GOV.UK
(non-sterile products only) Declaration of conformity Apply CE mark and notified body number Annex V: Production quality assurance. Audit by a notified body including QMS (excluding design) Class IIb medical devices – routes to CE marking Or Annex V1: Inspection quality assurance (non-sterile products only). Audit by a notified body including QMS
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