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The impact of CE marking: is there a down side?
1Evaluation and Standards Laboratory, CPHL, 61 Colindale Avenue, London NW9 5DE.
Communicable Disease and Public Health
|April 8, 2004
Summary
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.