European Directives and future Regulation 2017/745 on Medical Devices require the implementation of a post-market surveillance system, in order to monitor product performance in the post-production phase and take actions according to the feedback received.
The system should identify methods for collection of the information, approach used to evaluate collected data and the means to implement any necessary action resulting from the information collected on the product.
The post-marketing surveillance system according to MDR 2017/745 must be implemented by all medical device manufacturers from 26 May 2020 (date of application of the Regulation); this also applies to medical devices with a CE certificate issued in accordance with the Directives and still valid after 26 May 2020.
Whether you are based in Europe, or in any part of the world, Merc will support you with the development and implementation of a post-market surveillance system, including MDR 2017/745 requirements.
The Surveillance service of Merc covers also activities outside Europe.Request information