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

2. 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

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?
Reference materials
In-house NATs
Extraction kits

6. 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

7. 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

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?
Reference materials
In-house NATs
Extraction kits ? ?