Ce mark issues pei view
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CE mark issues -- PEI view. Micha Nübling, PEI. CE mark: conformity with requirements. IVD Directive (98/79/EC). requirements for placing IVDs onto the European market. free movement in the common market. CE Marking of most IVDs. IVD Dir. Manufacturer. User.

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Ce mark issues pei view

CE mark issues--PEI view

Micha Nübling, PEI


Requirements for placing ivds onto the european market

  • CE mark: conformity with requirements

IVD Directive (98/79/EC)

requirements for placing IVDs onto the European market

  • free movement in the common market


Ce mark issues pei view

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 mark issues pei view

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


Ce mark issues pei view

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


Ce mark issues pei view

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


Ce mark issues pei view

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.


Ce mark issues pei view

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


Ce mark issues pei view

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 ??


Ce mark issues pei view

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 kits1

?

Reference materials

In-house NATs

Extraction kits

?

?


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