CE-marking process for medical devices under Medical Device Regulation (MDR)

Medical device classification

In Europe, medical devices are classified using a series of rules outlined in Annex VIII of the MDR. Importantly, a product that holds a specific classification in China, Brazil, USA, or Canada may carry a different classification in Europe. This variation in classification necessitates a thorough and accurate evaluation of the classification criteria for each market.

Technical documentation

Technical documentation is a fundamental requirement for medical devices across all classes. It plays a pivotal role in the CE-marking process under the Medical Devices Regulation. It serves as a comprehensive record of a medical device's design, development, manufacturing, and performance data, ensuring that the device meets the applicable requirements for safety and performance set forth in the MDR.

Quality system compliance

The Quality Management System (QMS) is a critical aspect of the CE-marking process under the Medical Devices Regulation. It serves as a systematic framework that ensures medical device manufacturers adhere to the quality standards throughout the device's lifecycle – from design and development to production, distribution, and post-market activities.

EU Authorised Representative

For companies without a physical presence in the European Union, the appointment of an Authorised Representative (EC REP) is a mandatory requirement. At our company, we offer our services as your EC REP, ensuring seamless regulatory representation and compliance in the European Union for your medical devices.

Audit and certification support

Manufacturers seeking CE certification for Class I Sterile / Measuring / Reusable surgical instruments or higher class devices are subject to annual audits by Notified Bodies. To help you prepare and ensure a smooth process, we offer pre-assessment and maintenance audits prior to the official Notified Body audits.