Hi Franky, We have the following memorandum with our critical suppliers to comply with IVDR requirements. I hope this helps.
This memorandum has been created for all Canterbury Scientific Limited critical suppliers. This memorandum identifies the requirements for Notified Body to audit our critical suppliers, under our prudent attempt to achieve compliance to In Vitro Diagnostic Medical Device Regulation 2017/746 and requests you to kindly read and acknowledge the following.
Product registration: To place the product on the market in various countries, Canterbury Scientific Limited (CSL) must comply with applicable directives, regulations, and laws (e.g., the European In Vitro Diagnostic (IVD) Medical Device Directive 98/79/EEC or IVD Regulation 2017/746, US Food and Drug Act). Compliance to these directives, regulations, and laws may require information related to the product or manufacturing process to be submitted with relevant regulatory authorities (e.g., US Food and Drug Administration, European Commission, MHRA), authorized organizations, or by third parties commissioned by CSL. Supplier agrees to provide CSL with information related to the manufacturing, processing, finishing, testing, packaging, labeling, storage, or shipment as needed to register products in the intended countries where product will be placed on the market.
Third party audit: An audit or regulatory inspection may be required from time to time. This may involve the authority having jurisdiction over CSL according to the European In Vitro Diagnostic (IVD) Medical Device Directive 98/79/EEC or IVD Regulation 2017/746 or any other regulatory authority (e.g., US Food and Drug Administration, European Commission, MHRA) or authorized organization or by third parties commissioned by CSL. The regulatory authority may or may not announce the audit to CSL or the Supplier prior to the audit date (referred to as "unannounced audit"). Supplier must have a procedure in place to describe how the Supplier supports audits.
External audit support: Supplier shall use their best efforts to answer specific questions relating to quality assurance, quality systems, and regulatory as soon as possible upon CSL's request. Additionally, a copy of a record(s) is to be made available to CSL within two (2) business days upon request from CSL. These requests may be made to support external audits of CSL, such as an FDA inspection, Notified Body audits. In the event confidential information is requested by external regulatory authorities or governmental and external agencies (i.e. FDA, Notified Bodies), and permitted by the current regulations applicable for the product, files can be sent directly to the authorizing body without providing a copy to CSL.
Action by approving Official:
I have reviewed the above-stated facts and concur with the requirements stated in this notification memorandum.
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Murtuza Bohari
Quality and Regulatory Manager
Canterbury Scientific Limited
Christchurch, New Zealand
mbohari@canterburyscientific.com+64 21756098
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Original Message:
Sent: 10-Feb-2021 05:43
From: Franky Dubois
Subject: Critical Suppliers
Thanks
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Franky Dubois
QA/RA Manager
Gent
Belgium
Original Message:
Sent: 09-Feb-2021 08:40
From: YASSER ESTAFANOUS
Subject: Critical Suppliers
here attached our template
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YASSER ESTAFANOUS
Director of RA/QA
Winter Haven FL
United States
Original Message:
Sent: 05-Feb-2021 02:29
From: Franky Dubois
Subject: Critical Suppliers
Hello,
does anyone have an example of a contract addendum for critical suppliers to get their agreement for audits by your Notified Body?
Greetings,
Franky
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Franky Dubois
QA/RA Manager
Gent
Belgium
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