CE Mark for Medical Device
Explore the key regulations necessary to obtain CE marking for medical devices. As CE mark medical device consultants, we’ll provide a step-by-step guide on how to get CE marking for your medical device.
What is the CE Mark for Medical Devices?
CE Marking is a mandatory requirement for medical devices being sold in the European Union (EU). It signifies that the medical device complies with the relevant EU regulations, allowing for its commercialization across EU member states.
The same requirements apply to manufacturers of in vitro diagnostic (IVD) medical devices seeking CE Marking in Europe.
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Why Is the CE Mark Important for Medical Devices?
CE mark allows for legal sale and distribution within the European Economic Area (EEA) and demonstrates that the devices are safe and of high quality. The CE mark is crucial for market access, enabling manufacturers to expand their business and reach customers in EEA countries.
How to Get CE Mark for Medical Devices?
Getting the CE mark for medical devices involves several important steps. Here’s a comprehensive guide to help you through the CE mark process for medical devices:
- Determine Your Medical Device Classification: Classify your medical device according to its risk level, body placement, and duration of use. The classification ranges from Class I (lowest risk) to Class III (highest risk).
- Designate a Person Responsible for Regulatory Compliance (CE PRRC): Appoint at least one person in your company with expertise in medical devices to be responsible for regulatory compliance.
- Implement a Quality and Risk Management System: Establish a quality and risk management system compliant with ISO 13485:2016 or other relevant standards.
- Prepare Technical Documentation: Create detailed technical documentation or medical device technical files, including design control, manufacturing information, risk analysis, and post-market surveillance plans. Keep these documents accessible and well-organized for 10 to 15 years, depending on device classification.
- Implement Supplier Management System: Manage suppliers to ensure compliance with requirements and conformity. Maintain an Approved Supplier List (ASL) and conduct audits as necessary.
- Conduct a Clinical Evaluation: Perform a clinical evaluation to demonstrate conformity with safety and performance requirements. For Class IIb and III devices, consult an expert panel.
- Assign a European-Authorized Representative (if Applicable): If your company is not based in the EU, appoint an authorized representative within the member countries to handle documentation and regulatory matters.
- Obtain Certification by a Notified Body:For higher-risk devices (Class IIb and III), certification by a Notified Body is mandatory. The Notified Body will audit your QMS and technical documentation.
- Prepare a Declaration of Conformity: Once certified by a Notified Body, issue a Declaration of Conformity, stating that your device meets all MDR requirements.
- Register Your Device Under a Unique Device Identifier (UDI): Assign a unique device identifier to your device model and register it in the European Database on Medical Devices (EUDAMED) for traceability purposes.
- Affix a CE Marking to the Medical Device: After approval and certification, affix the CE marking on your medical device, packaging, and instructions for use. For Class II and III devices, include the four-digit number of the Notified Body.
- Maintain Post-Market Surveillance: Establish a post-market surveillance system to collect data on safety and effectiveness. Monitor complaints, adverse events, and non-conformities and keep technical documentation updated.
By following these steps, you can navigate the process of obtaining CE marking for your medical device and ensure its compliance with EU regulations.
Why Choose Operon Strategist?
Operon Strategist provides valuable CE certification consultancy services to medical device manufacturers. We understand the complexities of the CE marking approval procedure and offer experienced advice throughout the entire process. Manufacturers can easily classify their products, compile technical dossiers, conduct clinical studies, and submit to Notified Bodies using our end-to-end solutions. The customized solutions offered by Operon Strategist suit the specific needs of manufacturers, providing cost-effective and timely deliveries.
Because of our global presence and commitment to high standards, we are a reliable partner in achieving regulatory compliance. Whether it is CE certification or regulatory support in other countries, Operon Strategist offers comprehensive solutions to help businesses shorten the clearance process and successfully bring their goods to market.
To explore how Operon Strategist can assist you with obtaining CE marking for your medical product in Europe, contact us at enquiry@operonstrategist.comor via WhatsApp.