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CE Marking and Conformity of In Vitro Diagnostic Devices Under IVD Directive 98/79/EC

This document provides an overview of the CE marking process for In Vitro Diagnostic (IVD) devices in accordance with the IVD Directive 98/79/EC. It outlines essential requirements, harmonized standards, and quality assurance systems necessary for manufacturers to ensure compliance. The text discusses the classification of high-risk IVDs, including testing protocols and batch release requirements. It emphasizes the importance of reference materials, including in-house NATs and extraction kits, while differentiating between regulated and non-regulated materials. Key interpretations and German regulations regarding in-house assays are also addressed.

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CE Marking and Conformity of In Vitro Diagnostic Devices Under IVD Directive 98/79/EC

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Presentation Transcript

  1. CE mark issues--PEI view Micha Nübling, PEI

  2. CE mark: conformity with requirements IVD Directive (98/79/EC) requirements for placing IVDs onto the European market • free movement in the common market

  3. CE Marking of most IVDs IVD Dir Manufacturer User • Essential requirements • Harmonised Standards • Risk Analysis *Quality assurance system *Technical documentation *Post production review system

  4. CE Marking of „high risk“ IVDs (HIV, HBV, HCV; ...) IVD Dir NB Manufacturer User Batch release testing * CTS *Quality assurance system *Technical documentation *Post production review system

  5. ? Reference materials In-house NATs Extraction kits

  6. IVD Directive (98/79/EC) and reference materials Whereas (9)…… „not covered by IVD Dir: internationally certified reference materials and materials used for external quality assessment schemes…“ „covered by IVD Dir: calibrators and controls… for establishing or verifying performance…“ WHO IS, EU BRP reference materials, run controls

  7. IVD Directive (98/79/EC) and reference materials Approach of PEI CE marking of PEI‘s reference materials / standards (by Dec 2005). PEI-IVD lab accredited (ISO EN 17025) „old“ reference preparations (e.g. antiHBe IgG): some lack of data (e.g. source, manufacture) versus proof of suitability, performance data

  8. IVD Directive (98/79/EC) and in-house NATs Whereas (10)…… not covered by IVD Dir: reagents produced within health institution laboratories for use in that environment…and not subject to commercial transactions“ Art 1 (5) Member State has the right to….appropriate protection requirements.

  9. IVD Directive (98/79/EC) and in-house NATs German law on medical devices „in-house assays used for medicinal analysis in a professional and commercial environment have to undergo CE-Marking“ PEI‘s interpretation for blood bank in-house NATs NATs in blood banks are performed as quality control for blood products, not for medicinal analysis of donors. Blood banks = commercial ?? Assurance of state of the art: validation of assays + regular PTS

  10. IVD Directive (98/79/EC) and extraction kits Art 1 (2b) Scope, definitions „IVD = reagent (product), kit, instrument, …. …used alone or in combination …intended by the manufacturer to be used for in vitro examination for the purpose of providing diagnostic information…“ CE mark for extraction kits for diagnostic NATs ??

  11. IVD Directive (98/79/EC) and extraction kits PEI‘s interpretation: Extraction kits for diagnostic NATs = „reagents …used in combination…for in vitro examination for the purpose of providing diagnostic information“ = critical part of NAT systems EDMA‘s interpretation: Extraction kits are no IVDs since they cannot provide diagnostic information on ist own.

  12. ? Reference materials In-house NATs Extraction kits ? ?

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