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Glossary

Important Missing Information

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Critical gaps in knowledge for specific safety issues or populations that use the marketed product.

Other glossary definitions

I

In Vitro Diagnostic Medical Device (IVDMD)

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…

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P

Personal Data

Any information relating to an identified or identifiable individual; an identifiable person is someone who…

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