Tag Archives: CE mark

PIP implants – from CE marks to ISO accreditation?

The French court ordered TUV Rheinland was ordered to pay compensation to victims of defective PIP breast implants.  The French regulator, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), probably regrets delegating this task to them in the first place. … Continue reading

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Cartel and regulatory failures in the quality of diagnostic tests

For years Oxoid had been covering up erratic quality in the antibiotic testing discs they produced.  These were reference materials that accredited laboratories relied upon to measure microbial resistance and the correct antimicrobial dose to prescribe.  These actions would have led … Continue reading

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Tools of the cartel: Redefinition

How does the inspection cartel avoid admitting it enforces a cosy monopoly while also compelling markets to be “free”? By redefining its regulatory impositions as a “public authority activity” without economic consequence: “3.3 Is this Regulation creating a monopoly? Accreditation is not … Continue reading

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