Be confident of medical device market approval
From 26 May 2021, the EU Medical Device Regulation, (MDR (EU) 2017/745) has replaced the EU’s Medical Device Directive (93/42/EEC). Devices holding a certificate from a European Notified Body under Medical Device Directive (93/42/EEC) have an additional grace period and may continue to be placed on the market until 26 May 2024 if the manufacturer fulfil the specific prerequisite requirements drawn in the MDR.
Click here for more information about the Medical Device Regulation.
By complying with the requirements of the EU’s MDR and other regulations that apply to medical devices, manufacturers can tap into the European marketplace which consists of 500 million consumers. TÜV SÜD Product Service is one of the largest EU Notified Body for medical devices covered by MDR. Our extensive network makes TÜV SÜD Product Service an effective single source for manufacturers seeking expertise in the testing and certification of medical devices to EU requirements, as well as regulations applicable to these devices in other major medical device markets.
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