CE Marking

Navigating the complexities of CE marking can be challenging, but our experienced team is here to streamline the process for you. CE marking is a crucial certification that signifies your product meets the essential health, safety, and environmental requirements set by the European Union. A CE Mark is essential for selling medical devices within Europe. Without this certification, your device cannot be marketed in the European market. The CE Mark confirms compliance with specific EU regulations, which may involve self-assessment or working with an EU certification body, depending on the classification of your device. To obtain the CE Mark, you must adhere to one of the below relevant directives:

• The EU Medical Device Regulation (MDR),

• The In-Vitro Diagnostic Regulation (IVDR),

• The Active Implantable Medical Device Directive (AIMDD).

At RegR Consultants, we offer CE Marking services to guide you through the complex certification process. Our comprehensive CE marking services guide you through every step, from understanding the applicable directives and harmonized standards to conducting thorough product assessments and ensuring compliance. Our experienced team helps determine the best approach for your device and supports you throughout every step of the CE Mark. We provide tailored solutions to meet your needs. Our services include device classification, technical file preparation, and assistance with certifying body selection. With our dedicated team, you can be confident of easily navigating the CE marking process efficiently and effectively, allowing you to focus on growing your business while we handle the complexities of regulatory compliance.

• Our CE Mark Services Include:

  • Assistance with Device Classification

  • Technical File Preparation