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The impact of CE marking: is there a down side?

I R Sharp1

  • 1Evaluation and Standards Laboratory, CPHL, 61 Colindale Avenue, London NW9 5DE.

Communicable Disease and Public Health
|April 8, 2004
PubMed

Insights

The In Vitro Diagnostic Device Directive (IVDD) should not apply to in-house laboratory assays, as compliance is impractical and costly. Upholding this interpretation risks negatively impacting UK healthcare services and patient health.

Area of Science:

  • Clinical Pathology
  • Regulatory Science
  • Medical Laboratory Science

Background:

  • The In Vitro Diagnostic Device Directive (IVDD) aims to regulate medical devices placed on the market.
  • Healthcare institutions produce in-house assays not intended for commercial sale.

Purpose of the Study:

  • To evaluate the implications of the MHRA's interpretation of the IVDD on in-house laboratory assays.
  • To highlight the impracticality and negative consequences of applying the IVDD to assays developed within healthcare settings.

Main Methods:

  • Analysis of the scope and intent of the IVDD.
  • Assessment of the potential impact of MHRA's interpretation on pathology services across the UK.

Main Results:

  • The IVDD was not designed for in-house assays, making compliance impractical for healthcare institutions.
  • The MHRA's interpretation could divert funds, stifle innovation, and negatively affect pathology services and national health.

Conclusions:

  • Applying the IVDD to in-house assays is detrimental to the efficacy of UK pathology services.
  • The principles of the IVDD are sound for market-placed IVDs but not for internal laboratory use.

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