Our experienced consultants will provide you the service of reviewing your Technical File, registering your medical device or IVD, as required, and responding to any questions or concerns from the European Competent Authorities. Also, our expert consultants will send frequent updates to all our European Medical Device Authorized Representation clients with important regulatory updates focused on Europe, as part of our European Medical Product Authorized Representative service.
Introduction
The European Union (EU) requires that medical products marketed within its member states comply with specific regulatory requirements to ensure safety, health, and environmental protection. One key aspect of this regulatory framework is the CE marking, a certification mark that indicates conformity with those specific standards. For non-EU manufacturers, appointing an EU Authorized Representative (EUAR) is a crucial step in the CE marking process. This blog aims to provide a comprehensive overview of the role of the EU Authorized Representative and the process for obtaining CE marking for medical products.
The Role of the EU Authorized Representative
An EU Authorized Representative is a natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU to act on their behalf concerning specified tasks. The EUAR is essential for non-EU manufacturers, as they serve as the primary point of contact with EU regulatory authorities and are responsible for ensuring that the manufacturer’s products comply with applicable EU legislation.
Responsibilities of the EU Authorized Representative
- Regulatory Compliance: Ensure that the manufacturer’s products meet all applicable EU requirements.
- Technical Documentation: Maintain the technical documentation and the EU Declaration of Conformity.
- Vigilance and Post-Market Surveillance: Cooperate with EU authorities on post-market surveillance and vigilance activities.
- Incident Reporting: Report any serious incidents and field safety corrective actions to the competent authorities.
- Communication: Serve as the primary point of contact between the manufacturer and EU regulatory bodies.
The CE Marking Process for Medical Products
The CE marking process for medical products involves several steps to ensure compliance with the EU Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746.
Step 1: Determine the Applicable Regulations and Classification
- Identify Applicable Regulations: Determine whether the product falls under the MDR or IVDR.
- Classify the Medical Device: Classify the medical device according to the risk categories defined in the regulations (Class I, IIa, IIb, III for MDR and Class A, B, C, D for IVDR).
Step 2: Establish a Quality Management System
- Quality Management System (QMS): Implement a QMS that complies with the ISO 13485 standard or an equivalent. This system should cover all aspects of design, manufacturing, and quality control.
Step 3: Prepare Technical Documentation
- Technical File: Compile a technical file that includes detailed information about the product, including design, manufacturing processes, risk management, and clinical evaluation.
- Clinical Evaluation Report: Conduct a clinical evaluation to demonstrate the safety and performance of the medical device.
Step 4: Conformity Assessment
- Self-Declaration or Notified Body Involvement: For low-risk devices (Class I), the manufacturer can self-declare conformity. For higher-risk devices (Class IIa, IIb, III), the manufacturer must involve a Notified Body.
- Notified Body Assessment: The Notified Body conducts an assessment of the technical documentation and the QMS to ensure compliance with the applicable regulations.
Step 5: EU Declaration of Conformity and CE Marking
- EU Declaration of Conformity: Draft and sign an EU Declaration of Conformity, stating that the product complies with the relevant EU legislation.
- Affix the CE Mark: Affix the CE mark to the product and packaging, ensuring it is visible, legible, and indelible.
Step 6: Register the Medical Device
- EUDAMED Registration: Register the medical device in the European Database on Medical Devices (EUDAMED).
- National Competent Authorities: Notify the relevant national competent authorities within the EU member states.
Conclusion
The process of obtaining CE marking for medical products is rigorous and requires meticulous planning and documentation. Non-EU manufacturers must appoint an EU Authorized Representative to facilitate compliance with EU regulations. By following the outlined steps and ensuring adherence to the MDR or IVDR, manufacturers can successfully navigate the CE marking process and market their medical products within the European Union.