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Vigilance | ||
| MEDDEV. 2.7.1 | Vigilance Requirements for Medical Devices The latest revision of MEDDEV. 2.7.1 explicitly establishes manufacturers' responsibility to ensure that the clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. This requirement persists over the whole life cycle of the product. The frequency in which the clinical evaluation needs to be updated depends on the invasiveness and risk associated with the medical device's application as well as on the level of research activity in the respective field of application. The publication of new, relevant study result furthermore necessitates an assessment of whether a revision of the clinical evaluation is required. |
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| This means that in addition to continuous conventional market observation, manufacturers have to implement a system that ensures vigilance with regards to clinical data, clinical studies and scientific research. This system has to take into account both manufacturers' own products and equivalent devices by competitors. |
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| Methods of Post-Market Clinical Follow-Up (PMCF) Monitoring of Literature A well-structured monitoring system for the available literature based on pre-defined criteria often is an effective form of post-marketing follow-up. Such a system ensures a continuous survey of new publications and, if possible, conferences in the field and their proceedings, helping to assess whether new findings are relevant with regards to the respective medical device. This assessment should take place at predefined, documented intervals. Depending on the outcome, the clinical evaluation may have to be revised. |
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| Observational Studies Observational studies are a suitable instrument for post-marketfollow-up. In these studies, collaboration with selected hospitals enables manufacturers to monitor their respective product in every-day use. While these studies are guided by protocols, they do not include any kind of interference with regular patient care or with the use of the respective medical device. |
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Possible forms of observational studies are non-interventional studies or registries. At predefined intervals, the results are analysed, which may lead to a revision of the clinical evaluation. The current EC guidelines require all manufacturers of medical devices to implement an appropriate form of vigilance. |