What is CE Medical?
CE Medical is our team specialised in the CE marking of Medical Devices. With over 25 years of experience and complete knowledge of the EU’s medical device classification standards, our medical consultants provide tailor-made solutions to ensure that your medical device and documentation meets all mandatory requirements.
CE-marking Medical Devices
In the context of medical devices, the CE marking signifies that a product complies with the essential requirements of the EU’s Medical Device Directive (MDD) or the Medical Devices Regulation (MDR), depending on the specific regulatory framework in place at the time of certification. The MDR replaced the MDD, and its implementation began in 2017.
For a medical device to bear the CE mark, manufacturers must meet various requirements, including product safety, performance, and quality standards (Quality Management Systems), as well as demonstrating compliance with relevant regulations and standards. CE marking is necessary to market and sell medical devices in the European Economic Area (EEA).
CE Medical Team
Our CE Medical Team is here to help you to navigate the compliance process, prepare the necessary documentation, implemente QMS and verify that your medical device(s) aligns with the safety objectives outlined in the MDD or MDR. This ensures your products can be confidently introduced to the EU mark. If you need any services with regard to the MDD, MDR or QMS, our team is readily available, please feel free to contact us.
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