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Glossary

Use error

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An act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user. This includes slips, lapses and mistakes. However, an unexpected physiological response of the subject does not in itself constitute a use error.

Other glossary definitions

P

Periodic Summary Reporting

Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for…

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I

Innovative Licensing and Access Pathway (ILAP)

The MHRA’s Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market,…

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