Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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IVDR Annex II, 3.2. Sites and subcontractors

‘The manufacturer shall provide …: Site and local manufacturer details … Site with design responsibility Site(s) performing production, assembly, final product testing, and packaging of the finished device … Where a service or production is outsourced provide the name and address of the critical subcontractors or suppliers (as per Commission Recommendation 2013/473/EU) ... Copies of critical subcontractor and suppliers ISO 13485 certificates …'

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, 3.2. Sites and subcontractors

‘For critical suppliers and /or subcontractors satisfactory evidence that the purchase critical products or service meet the specified requirements shall be shown (e.g., EN ISO 13485 certificate, records of supplier audits, 100 % incoming inspection or any other control)’

‘… the notified body will then assess if an audit at the premises of the critical supplier and/or subcontractor is necessary. Relying on solely the supplier certification may not be considered sufficient.’

The Organisation for Professionals in Regulatory Affairs

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