July 17, 2019
How to incorporate Article 88 into Post Market Surveillance
 If a manufacturer detects an increase in reports related to expected side effects that might lead to death or a serious deterioration of patient health, this might signal a deterioration in the performance of the device or an off-label use of the device. While many manufacturers may not be in the habit submitting a trend report to the National Competent Authority (NCA) for non-serious incidents, it is required by Article 88 of the Medical Device Regulation (MDR) 2017/745

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Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

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  • We know exactly what should be prepared to become and stay in compliance with the regulations
  • Strong international team with technical, regulatory quality and clinical competence.
  • Ex EU Notified Body, FDA, and CFDA staff.
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  • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team.
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