CE Marking for Medical Devices
CE Marking of Medical Devices – Regulation (EU) 2017/745.
Medical devices placed on the European market must undergo a conformity assessment demonstrating compliance with the essential safety and performance requirements set forth in Regulation (EU) 2017/745 (MDR). This is not a formal procedure: it is a technical and documentary process requiring specialized expertise. MTM Consulting assists manufacturers and industry operators in preparing technical documentation and managing the conformity process.
What Regulation 2017/745 (MDR) Requires
Regulation (EU) 2017/745 replaced the previous Directive 93/42/EEC, introducing more stringent requirements for conformity assessment, post-market surveillance, and traceability. The main pillars of the conformity process are: alignment of the quality management system with the requirements of ISO 13485 standard and preparation of a complete technical file gathering all evidence necessary to demonstrate device conformity.
Required Technical Documentation
The technical documentation for a medical device compliant with Regulation (EU) 2017/745 must include:
- Device identification, including UDI (Unique Device Identifier) code
- Description, configurations, and accessories of the device
- Intended use and clinical indications
- Labeling and instructions for use
- Design and manufacturing information
- Risk management according to EN ISO 14971
- Verification and validation of conformity with general safety and performance requirements (GSPR)
- Post-market surveillance plan
The Role of Notified Bodies
Depending on the medical device class (I, IIa, IIb, III), the conformity process may require mandatory involvement of a notified body. Class I devices may be self-certified by the manufacturer. For higher classes, conformity assessment by an accredited notified body is required. MTM Consulting supports preparation for assessment and manages the relationship with notified bodies.
How MTM Consulting Supports MDR Compliance
- Device classification according to Regulation (EU) 2017/745
- Structuring and preparation of technical documentation
- Support for ISO 13485 compliance for the quality management system
- Assistance in document management and risk classification
- Preparation for conformity assessment with notified bodies
- Monitoring of applicable technical standards and regulatory updates
MTM Consulting operates from Monza and Turin for companies throughout Italy. Contact us for an initial assessment of your device and a customized quote.
RESOURCES.
- Directive 2006/42/EC - Machinery Directive
- Machinery Regulation (EU) 2023/1230
- Directive 2014/34/EU - ATEX Directive
- Directive 2014/68/EU - PED Directive
- Directive 2014/35/EU - Low Voltage Directive
- Directive 2014/30/EU - Electromagnetic Compatibility Directive
- Directive 2012/19/EU - WEEE Directive
- Directive 2011/65/EU - RoHS Directive
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