IVDR FAQ and Best Practices for The Vigilance of In Vitro Diagnostic Medical Devices

By |2022-11-10T22:46:47+00:00November 15th, 2022|

The purpose of vigilance is to protect the health and safety of patients, healthcare professionals, and other users by reducing the probability of reoccurring serious incidents related to in vitro diagnostic medical devices. For that to happen, EU member states and their national competent authorities must be aware of any serious incidents and actions are [...]

IVDR Part II – Your Technical Documentation and Performance Evaluation

By |2022-11-14T21:15:02+00:00June 12th, 2020|

What will the new EU regulations mean for in vitro diagnostics? In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. Manufacturers aiming for European market access to receive the CE label will face more stringent, more thorough considerations.   The [...]

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