Article 51 (o)

Data from research cohorts, questionnaires, and surveys related to health

Definition
Data from registries for medicinal products and medical devices refer to systematically collected data on the use, safety, effectiveness, and performance of medicinal products and medical devices. For medicinal products, registries track outcomes, adverse reactions, and long-term effects of drugs. For medical devices, they monitor safety, functionality, and post-market performance. These registries help ensure public safety, support regulatory decisions, and facilitate ongoing research and improvement of these products.
Examples for medicinal products
  • Adverse Event Reports: Data on negative side effects or reactions experienced by patients using the medicinal product. 

  • Treatment Outcomes: Information on how well the medicinal product is working in real-world settings, including improvements or failures in treating a disease or condition.

  • For medicinal products - Usage Patterns: Data on the frequency, dosage, and duration of use of the medicinal product by different populations.

  • Efficacy Data: Information on the effectiveness of the medicinal product in achieving its intended therapeutic goals.

  • Patient Demographics: Data on the age, gender, health status, and other demographic factors of patients using the medicinal product. 

  • Prescription Data: Information about how frequently and where the medicinal product is being prescribed.
Examples for medical devices:
  • Device Performance Data: Information on how well a device functions during real-world use, including any malfunctions or failures. 

  • Adverse Event Reports: Data on complications, injuries, or other adverse outcomes associated with the use of medical devices. 

  • Post-Market Surveillance Data: Data collected after the device has been marketed, tracking its ongoing safety and effectiveness. 

  • Patient Outcomes: Information on how the use of the medical device impacts patient health, including recovery rates or quality of life improvements. 

  • Device Longevity and Wear: Data on the durability and lifespan of medical devices, such as implants or prosthetics. 

  • Recall Information: Data related to any recalls of medical devices, including reasons for the recall and actions taken.

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