Module 17 2024

05/12/2024

Implementation of UA’s by Notified Bodies

• Critical Subcontractor – in charge of processes which are essential for ensuring compliance with legal requirements • Crucial Supplier – supplier of crucial components or of the entire device

The Organisation for Professionals in Regulatory Affairs

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Implementation of UA’s by Notified Bodies

• UAs are Product Audits; they are not QMS audits and are not ISO13485-related. • No pre-warning of UAs under any circumstances can be given to legal manufacturers. [Note: 1 hour’s notice on the way to the manufacturer is acceptable]. • “For Cause” UAs can be undertaken at any time. “For Cause” audits are generally requested by Competent Authorities. • General UAs must be completed every 5 years (MDR Annex IX 3.4). The frequency is increased for high-risk devices and for devices with a high incidence of nonconformities. *Note: Difference with MDD where General UAs were conducted every 3 years.

The Organisation for Professionals in Regulatory Affairs

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