This Position Paper is a Team-NB consensus document describing the pre-application, application and post-application processes through which manufacturers may apply to Notified Bodies for the certification of in vitro medical devices under IVDR.
What is new?
The paper was developed in consensus by reviewing the application process and associated documents of individual Team-NB members and harmonising the processes where possible, for the certification of in vitro medical devices (IVDs) under IVDR. The document applies to both legacy IVDs and IVDs that are new to the market. The document also briefly describes the certification activities, undertaken after the application process is concluded.
The paper gives a detailed overview of notified body expectations and activities during the different phases of certification, being: initial contact & pre-application submission; pre-application review and quotation process; formal application lodging; contract/written agreement and application review; conformity assessment; final review and decision making; certificate issuance; and surveillance activities. Specific, device-type procedures for conformity assessment are included, as well as a brief section on batch verification of class D IVDs. Finally, it includes a list of information/documents to be submitted by the manufacturer during pre-application and formal application.
What does it mean to you?
This Team-NB IVDR Certification Process Position Paper is important for all manufacturers of IVDs that require conformity assessment by a notified body. While every notified body may still have some specific requirements and/or expectations, this document provides manufacturers with valuable information on the certification process steps for their products under IVDR, regardless of which notified body they choose.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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