CE mark issues -- PEI view

1
CE mark issues--PEI view

• Micha Nübling, PEI

2
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 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
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 environmentand 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
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
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
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.
12
?

• Reference materials
• In-house NATs
• Extraction kits

?
?