The CE Mark is a crucial certification indicating compliance with European Union (EU) regulations for medical devices. In May 2017, the Medical Devices Regulation (MOR) 2017/745 was introduced to enhance safety and traceability in the medical device market. Compliance with these regulations is essential for manufacturers to legally market their products within the EU and European Economic Area (EEA).

Key aspects of compliance with MOR 2017/745 include:

•     Clinical Evaluation: Conducting comprehensive clinical evaluations to demonstrate the safety and performance of medical devices.
•     Post-Market Surveillance: Implementing robust systems for monitoring the performance and safety of devices post-market.
•     Quality Management Systems: Establishing and maintaining quality management systems in line with ISO 13485 standards.
•     Technical Documentation: Compiling thorough technical documentation that supports the safety, performance, and compliance of medical devices.
•     Achieving and maintaining CE Marking involves adherence to stringent regulatory requirements and may require the involvement of Authorized Representatives and regulatory bodies.