Obtaining CE marking for medical devices is a critical step for manufacturers looking to market their products within the European Economic Area (EEA). The CE mark signifies that a product meets the essential requirements of the relevant European health, safety, and environmental protection legislation. In this blog, we will share eleven key steps to walk you through the necessary requirements to achieve CE marking for your medical device.
1. Understand the Regulatory Framework
The regulatory framework for medical devices in the EU is governed by the following key regulations:
Medical Device Regulation (MDR) (EU) 2017/745:Â Applies to general medical devices.
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746:Â Applies to in vitro diagnostic devices.
These regulations replaced the previous Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) and introduced more stringent requirements to ensure high levels of safety and performance.
2. Determine the Device Classification
Medical devices are classified into four classes based on risk: Class I, Class IIa, Class IIb, and Class III. The classification determines the conformity assessment route and the involvement of a Notified Body.
Class I:Â Low risk (e.g., non-invasive devices)
Class IIa:Â Medium risk (e.g., surgical gloves)
Class IIb:Â Higher risk (e.g., long-term invasive devices)
Class III:Â Highest risk (e.g., implantable devices)
3. Conduct a Conformity Assessment
The conformity assessment process verifies that the device meets the essential requirements of the MDR or IVDR. The route depends on the device classification:
Class I Devices:Â Self-certification by the manufacturer is allowed (except for sterile or measuring devices, which require Notified Body involvement).
Class IIa, IIb, and III Devices: Require assessment by a Notified Body, which reviews the Technical Documentation and conducts audits of the manufacturer’s quality management system (QMS).
4. Prepare Technical Documentation
Comprehensive Technical Documentation must be prepared, including:
Device Description and Specifications:Â Detailed description of the device, intended use, and specifications.
Risk Management:Â Risk analysis and management reports in compliance with ISO 14971.
Design and Manufacturing Information:Â Details of the design and manufacturing processes.
Performance and Safety: Clinical data demonstrating the device’s performance and safety, including Clinical Evaluation Reports (CER).
Labeling and Instructions for Use:Â Labels, instructions, and promotional materials compliant with MDR/IVDR requirements.
5. Implement a Quality Management System (QMS)
Manufacturers must implement a QMS that complies with ISO 13485:2016, ensuring consistent product quality and regulatory compliance. The QMS should cover all aspects of design, manufacturing, and post-market surveillance.
6. Clinical Evaluation and Investigation
For Class IIa, IIb, and III devices, a Clinical Evaluation is required to demonstrate the device’s safety and performance based on clinical data. In some cases, Clinical Investigations (trials) may be necessary to gather sufficient data.
7. Appoint a Person Responsible for Regulatory Compliance (PRRC)
Manufacturers must appoint a PRRC who ensures the device’s compliance with the MDR or IVDR. The PRRC should have requisite expertise in regulatory affairs and quality management.
8. Compile the EU Declaration of Conformity
The EU Declaration of Conformity is a legally binding document declaring that the device meets all applicable requirements of the MDR or IVDR. It must include:
Device identification and description
Manufacturer’s details
Conformity assessment procedures followed
References to applicable regulations and standards
9. Engage with a Notified Body
For Class IIa, IIb, and III devices, manufacturers must select a Notified Body accredited to assess the conformity of their specific type of device. The Notified Body will review the Technical Documentation and perform audits of the QMS.
10. Obtain CE Marking and Register the Device
Once the Notified Body issues the CE certificate, the manufacturer can affix the CE mark to their device. The device must then be registered with the EUDAMED database, and the manufacturer must maintain ongoing compliance through post-market surveillance and vigilance activities.
11. Post-Market Surveillance and Vigilance
Manufacturers must establish and maintain a post-market surveillance system to monitor the performance and safety of the device once it is on the market. This includes:
Collecting and analyzing post-market data
Reporting incidents and field safety corrective actions (FSCA) to relevant authorities
Conducting periodic safety update reports (PSUR) for Class IIb and III devices
Conclusion
Obtaining CE marking for a medical device is a complex but essential process for accessing the European market. By adhering to the stringent requirements of the MDR or IVDR, manufacturers can ensure their devices meet the highest standards of safety and performance. At OneGlobal Trinity M Consulting, we offer expert guidance and support to help you navigate the regulatory landscape, ensuring your device achieves CE marking efficiently and effectively. Contact us today to learn more about our services and how we can assist you in bringing your innovative medical devices to market.
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