CE mark issues -- PEI view Micha Nübling, PEI

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

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

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

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

and reference materials 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

and reference materials 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

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.

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

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 ??

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.

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