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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Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.


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


We can help you navigate through the Chinese market by offering a wide range of customized services.


We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

Why choose Qserve as your regulatory consultant?


  • We know exactly what should be prepared to become and stay in compliance with the regulations
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  • Legal representation in China, Europe and United States


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"Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements."
Jan van Lochem , CEO