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Prepare clinical study in a reference laboratory

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Reference no: EM132819526

A company has a new self tested product for pregnancy that is wishes to CE mark as IVD per Directive 98/79/EC. Which action MUST the company take?

a. Submit a dossier for clearance under General Product safety

b. Prepare clinical study in a reference laboratory involving a minimum 500 samples

c. Conduct a sensitivity test using at least 200 urine samples from pregnant women

d. Evaluate the product with laypersons

Reference no: EM132819526

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