In-house IVDs (IH-IVDs or often called LDTs) are exempt from most provisions of Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR) provided they meet the conditions set out in Article 5(5) of the IVDR.
The Association of the Scientific Medical Societies in Germany (AWMF) ad hoc commission provides documents as recommendations and assistance for the following IVDR requirements:
- 5 (5 f): Public statement confirming compliance with general safety and performance requirements
- 5 (5): Determination and documentation of compliance with the general safety and performance requirements listed in Appendix I.
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- Detailed checklist in which each individual point of Annex I of the IVDR is addressed and evaluated. The 2nd tab is particularly helpful for laboratories that are accredited according to ISO15189.
- Compact checklist that queries the requirements of the IVDR for the commissioning of IH-IVD in the categories reagent, reagent product, calibrator, control material, kit.
- Appendix I chap. I: IVDR compliant risk management
- Appendix I, chap. II (9): IVDR compliant performance evaluation
- Handouts for validation of virological / microbiological examination methods