CE mark issues -PEI view Micha Nbling, PEI 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 Manufacturer Dir User Essential requirements *Quality assurance system Harmonised Standards *Technical documentation
Risk Analysis *Post production review system CE Marking of high risk IVDs (HIV, HBV, HCV; ...) IVD Manufacturer Dir
NB User Batch release testing * CTS *Quality assurance system *Technical documentation *Post production review system ?
Reference materials In-house NATs Extraction kits 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 WHO IS, EU BRP
covered by IVD Dir: calibrators and controls for establishing or verifying performance reference materials, run controls IVD Directive (98/79/EC) and reference materials Approach of PEI CE marking of PEIs 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 environmentand 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
PEIs 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 PEIs interpretation: Extraction kits for diagnostic NATs
= reagents used in combinationfor in vitro examination for the purpose of providing diagnostic information = critical part of NAT systems EDMAs interpretation: Extraction kits are no IVDs since they cannot provide diagnostic information on ist own. ? Reference materials In-house NATs
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