Medical Device CE Marking is essential for EU market access and compliance with the new MDR. The Medical Device Regulation (MDR 2017/745) sets the guidelines and details for the CE marking, ensuring that devices meet safety and performance requirements. Readers may find key components involved in achieving CE marking for medical devices, including the development of a technical file, the declaration of conformity, risk analysis, and clinical evaluation as per MDR Article 61.
MDR 2017/745: An Overview
The MDR 2017/745 came into effect to replace the previous Medical Device Directive (MDD). It has superseded MDD 93/42/EEC in the EU. The regulation introduces more rigorous requirements for clinical evidence, post-market surveillance, and transparency. Compliance with the MDR Regulation is mandatory for all medical devices sold in the EU, making the CE Certification process a crucial step for manufacturers.
Medical Device Technical File
A Medical Device technical documentation file is needed by the notified body during the CE certification process. This file must include detailed information about the medical device, models and variants covering design, QC, manufacturing processes, intended use, and performance. Key components of a technical documentation file include:
- Information about the device, including drawings, diagrams, and specifications.
- Manufacturing processes description, quality control measures, and production facilities.
- Comprehensive risk analysis and risk management plans.
- Clinical evaluation Report documentation covering clinical evidence supporting the device’s safety and performance.
- Samples of labels, packaging, and user manuals.
- A formal statement declaring the device’s compliance with applicable regulations.
- General Safety and Performance Report
- SSCP
- DOC
Declaration of Conformity (DOC)
The declaration of conformity is a formal statement made and signed by a top-level employee/person by the manufacturer asserting that the medical device meets all relevant requirements of the MDR 2017/745. This declaration must be supported by evidence, including the technical file, risk analysis, and clinical evaluation. It should include the following elements:
- Manufacturer representative Name, address, and contact details.
- Device intended use, class and rule, including model and serial numbers.
- EU harmonized standards and non-harmonized standards
- Conformity Assessment Procedure followed.
- Signature of a responsible person within the organization.
- Date of signing of DOC
- CE Certification details with date of issue
Risk Analysis
Risk analysis is important during the design phase of the medical device and throughout the device life cycle. It involves identifying potential hazards associated with the use and handling of medical devices and evaluating the risks to users and patients. The process includes:
- Identification of Hazard
- Risk evaluation
- Adapt risk control measures
- Residual risk assessment and documentation
- Risk management report compilation
Clinical Evaluation as per MDR Article 61
Article 61 of the MDR 2017/745 outlines the requirements for clinical evaluation. This process involves systematically assessing clinical data to verify the safety and performance of the medical device. Key steps include:
- Search, gather and analyse existing scientific literature related to the device.
- Conducting clinical studies if necessary to gather additional data.
- Evaluating clinical data to demonstrate compliance with safety and performance
- Clinical Evaluation Report (CER) covering full documentation of the findings with conclusions
Conclusion
CE marking for medical devices under the MDR 2017/745 involves the need for a consultant like the I3CGLOBAL team for guidance and notified body coordination. Consultants compile a detailed technical file and make a declaration of conformity to conducting a comprehensive risk analysis and clinical evaluation, each step is crucial for demonstrating compliance with MDR 2017/745 requirements. By adhering to these stringent requirements, manufacturers can ensure that their medical devices meet the highest standards of safety and performance, ultimately benefiting patients and healthcare providers across the EU.
