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

The process of obtaining CE-marking under MDR (Medical Device Regulation) is a vital undertaking for medical device manufacturers seeking compliance and access to the European market. MDRC provides 360° regulatory assistance to medical device companies, encompassing technical documentation, registration, representation, and quality system compliance, as depicted in the following diagram.

Determine the CLASSIFICATION of your device using Annex VIII of the Medical Device Regulation Class I Non-sterile Non-measuringNot reusable surgical instruments Class I Sterile MeasuringReusable surgical instruments Class IIa Class IIb Class III Implement QUALITY MANAGEMENT SYSTEM (QMS) in accordance with MDR Most companies apply the ISO 13485 standard to achieve QMS compliance. Prepare a TECHNICAL DOCUMENTATION which provides detailed information demonstrating compliance with the Medical Devices Regulation EC 2017/745. Appoint an AUTHORISED REPRESENTATIVE (EC REP) located in Europe and qualified to handle regulatory issues. Place EC REP name and address on packaging. Register the manufacturer and the medical device in the EUDAMED database. As a result you will get the unique device identifier (UDI). Your QMS and Technical File or DESIGN DOSSIER must be audited by a Notified Body. A CE Certificate for your device will be issued upon successful completion of the Notified Body audit. Prepare a DECLARATION OF CONFORMITY, a legally binding document prepared by the manufacturer stating that the device is in compliance with the applicable Regulation. You may now affix the CE Marking.

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.

Partner with us, and let our regulatory expertise guide you towards regulatory success in Europe!

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