Overview of EU 2017/745 Medical Device Regulation (MDR)
The EU Medical Device Regulation (MDR) 2017/745 is a robust regulatory framework governing the design, manufacture, distribution, and post-market surveillance of medical devices within the European Union. It replaced the previous Medical Device Directive (MDD) and became fully enforceable on May 26, 2021. Compliance with the MDR is mandatory for manufacturers seeking to market their medical devices in the EU.
At Medral Global, we specialize in guiding manufacturers through MDR compliance to ensure their devices meet all regulatory requirements and maintain smooth market access within the EU.
Key Highlights
CE Marking:
Devices must carry the CE mark, indicating compliance with EU safety, performance, and quality standards.
Objectives:
- Enhance Patient Safety: Stricter clinical evaluation and post-market surveillance.
- Ensure Quality & Performance: Mandatory Quality Management Systems (QMS).
- Increase Transparency: Unique Device Identification (UDI) system and publicly available device information.
Major Requirements Under MDR
- CE Marking: Demonstrates conformity with regulatory requirements for market access.
- Technical Documentation: Detailed records of device design, manufacturing, clinical evaluation, and risk management.
- Clinical Evaluation: Pre-market and post-market clinical investigations to validate device safety and efficacy.
- Quality Management System (QMS): Continuous control of manufacturing and post-market activities.
- Risk Management: Identifying and mitigating device risks throughout its lifecycle.
- Post-Market Surveillance: Ongoing monitoring of device performance and safety after market release.
- Notified Bodies: Independent organizations assess and certify device conformity.
Medical Device Classification (Article 51 & Annex VIII)
Devices are classified based on risk, intended use, and duration of contact with the body:
| Class | Risk Level | Examples | Certification |
|---|---|---|---|
| Class I | Low risk | Bandages, stethoscopes, non-powered wheelchairs | Self-certification (some require Notified Body if sterile or measuring) |
| Class IIa | Medium risk | Hearing aids, ultrasound machines | Notified Body |
| Class IIb | Medium to high risk | Infusion pumps, ventilators | Notified Body |
| Class III | High risk | Pacemakers, heart valves, implantable defibrillators | Notified Body |
- Non-invasive devices are mostly Class I or IIa.
- Invasive devices range from Class IIa to III depending on risk.
- Active devices powered by external sources are typically Class IIb or III.
- Duration of use also impacts classification: transient (<60 min), short-term (60 min–30 days), and long-term (>30 days).
Classification Rules (Annex VIII)
- Rules 1-4: Non-invasive devices.
- Rules 5-8: Invasive devices.
- Rules 9-13: Active devices powered externally.
- Rules 14-22: Special rules for certain types and aspects of devices.
Special Considerations — Annex XVI: Beauty and Cosmetic Devices
The MDR now covers many aesthetic devices to ensure safety:
- Contact lenses (including non-prescription colored lenses).
- Cosmetic implants (e.g., breast implants for aesthetic purposes).
- Cosmetic fillers (lip augmentation, wrinkle reduction).
- Liposuction and related devices.
- Light-emitting devices (lasers, IPL for hair removal, tattoo removal).
- Brain stimulation devices (used to influence mood).
Why MDR Matters
The MDR ensures that every medical device placed on the EU market meets high safety, efficacy, and quality standards, protecting patients and users while providing manufacturers with a clear regulatory pathway for market access.
At Medral Global, we are committed to helping you navigate these complex requirements efficiently and successfully.