EU MDR 2017/745 Compliance
The European Union Medical Device Regulation (EU MDR 2017/745) came into full effect on May 26, 2021, replacing the long-standing Medical Device Directive (MDD 93/42/EEC). This regulation introduces a more robust, transparent, and patient-centered framework for medical device oversight across the EU. It significantly raises the bar for safety, performance, and post-market surveillance, impacting manufacturers, importers, and authorized representatives alike.
Key Requirements of EU MDR 2017/745
The MDR introduces several core obligations for all economic operators:
- Stricter classification rules based on risk, duration of contact, and invasiveness.
- Expanded scope to include certain aesthetic devices and software.
- Unique Device Identification (UDI) for traceability.
- Mandatory registration in EUDAMED, the EU’s central device database.
- Greater emphasis on clinical evidence, post-market surveillance, and transparency.
Comparison with MDD 93/42/EEC
| Aspect | MDD 93/42/EEC | MDR 2017/745 |
|---|---|---|
| Classification | Risk-based, less granular | More detailed rules, new subcategories (e.g., Class Ir) |
| Clinical Evaluation | Often based on equivalence | Requires direct clinical data and stronger justification |
| Post-Market Surveillance (PMS) | Limited requirements | Mandatory PMS plans and reporting |
| Periodic Safety Update Report (PSUR) | Not required | Required for Class IIa, IIb, and III devices |
| Technical Documentation | Less prescriptive | Detailed structure and content required |
| Transparency | Limited public access | SSCP and EUDAMED improve public and regulator access |
Technical File Requirements
Under MDR, the technical documentation must include:
- Device description and specification
- Design and manufacturing information
- Risk management documentation (per ISO 14971)
- Clinical evaluation report
- Biological safety evaluation
- Labeling and IFU
- PMS and PSUR plans
- SSCP (for Class III and implantable devices)
Clinical Evaluation
Clinical evaluation under MDR must be:
- Based on robust clinical data, not solely equivalence
- Supported by clinical investigations for higher-risk devices
- Continuously updated through post-market clinical follow-up (PMCF)
Biological Evaluation
Biocompatibility must be demonstrated per EN ISO 10993 series, with:
- Cytotoxicity, sensitization, irritation tests
- Justification for material selection
- Integration with risk management and clinical evaluation
SSCP – Summary of Safety and Clinical Performance
Required for:
- Class III and implantable devices
- Must be written in layperson language
- Published in EUDAMED for transparency
PMS and PSUR Requirements by Device Class
| Class | PMS Plan | PSUR | SSCP |
|---|---|---|---|
| Class I | Required | Not required | Not required |
| Class Ir (reusable surgical) | Required | Not required | Not required |
| Class IIa | Required | Required (updated every 2 years) | Not required |
| Class IIb | Required | Required (updated annually) | Not required |
| Class III | Required | Required (updated annually) | Required |
Conclusion
The EU MDR 2017/745 represents a paradigm shift in medical device regulation. It demands greater accountability, scientific rigor, and transparency from manufacturers. While the transition from MDD has posed challenges, it ultimately strengthens patient safety and regulatory trust across Europe.