On March 1st, 2023, Team NB released a new position paper on best practice guidance for the submission of technical documentation under Annex II and Annex III of the European (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR). This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.
Manufacturers of all Classes of IVD medical devices (IVD) are expected to demonstrate conformity of the IVD to the General Safety and Performance Requirements (GSPR) of the IVDR through the preparation and holding of technical documentation that shows how each IVD was developed, designed, and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity. This technical documentation is intended to reflect the current status of the IVD through application of the manufacturer’s QMS.
The technical documentation reflects the status of the IVD at a particular moment in time (e.g., at the moment of premarket submission or when requested for post-market purposes) and is prepared in order to meet the applicable regulatory requirements and more specifically the GSPR. Where the technical documentation is submitted to a Notified Body (NB), it should be in a language acceptable to the reviewing organization.
This technical documentation submission guidance is aligned to the requirements of the IVDR, described in detail in Annexes II and III, and Article 29.
Beside an in depth assessment of each section on Annex II and III, this best practice document also discusses general considerations that manufacturers should take into account when submitting a file for review and also shared additional requirements to be taken into account for companion diagnostics.
What does this mean to you?
This position paper from Team NB is off relevance for all IVD manufacturers to ensure your technical documentation is aligned with Notified Body expectations. Our Technical Documentation Services experts are here to guide you in case you need assistance with your technical documentation.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
