In recent years, the European regulatory framework for medical devices (MDs) has undergone a major transformation. The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) has introduced significant changes aimed at ensuring greater safety, transparency, and quality for patients and users.
1. Enhanced Protection and Safety
- MDR: The MDR ensures greater safety of medical devices, enforced by both the manufacturer and the notified body that certifies the device. For example, it requires more rigorous post-market surveillance and stricter risk management, with a focus on patient interaction.
- MDD: While the MDD already provided a level of protection, the MDR raises the standards to minimize risks associated with MDs, especially high-risk devices such as implants or surgical instruments.
2. Improved Identification and Traceability
- MDR: Enforces stricter traceability throughout the entire lifecycle of the device, from production to final use. Each MD must carry a UDI-DI (device identifier) and a UDI-PI (production identifier), which help ensure timely recalls and better safety issue management.
- MDD: The MDD included some traceability measures, but they were less centralized and detailed.
3. More Rigorous Clinical Evaluation
- MDR: For higher-risk devices, the MDR requires a more thorough clinical evaluation and the compilation of highly detailed technical documentation, which must be continuously updated. This ensures ongoing monitoring of the device’s effectiveness and safety.
- MDD: The MDD did not impose the same level of rigor, allowing for less long-term oversight.
4. Clearer Labeling Requirements
- MDR: Introduces more detailed labeling requirements and consumer information, including clearer descriptions of risks and contraindications. Labels must be easy to understand and provide complete information.
- MDD: Labeling was less detailed compared to the standards set by the MDR.
5. High-Risk Devices
- MDR: Reclassifies certain devices from “low risk” to “high risk,” meaning they are now subject to stricter control and regulation.
- MDD: Some devices now considered high-risk under MDR were previously classified as low-risk under MDD.
6. Post-Market Surveillance
- MDR: Introduces much stricter requirements for post-market surveillance, obliging manufacturers to collect data on adverse events and take swift action in case of safety issues.
- MDD: Post-market monitoring was less detailed and required less transparency.
7. Greater Involvement of Competent Authorities
- MDR: Competent authorities now have greater powers of oversight and control, allowing
- MDD: Authorities had similar powers, but fewer specific tools to enforce compliance compared to MDR.
8. Increased Transparency
- MDR: Requires greater transparency through public disclosure and registration in EUDAMED, the European Database on Medical Devices. This includes manufacturer registrations, certifications, device information, and reports of adverse events.
- MDD: The previous directive introduced some transparency measures, but not with the same level of detail and centralization. EUDAMED was foreseen but its use was less extensive and centralized.
Conclusion
For consumers, the main differences lie in improved safety, traceability, and transparency throughout the approval, use, and monitoring processes of medical devices. The MDR provides stronger protection, ensuring that devices are not only safe at the time of market entry but also continuously monitored to prevent long-term risks.
Download our free guide and discover the 5 key steps to navigate the new regulations and adapt your medical or dental practice, avoiding penalties while ensuring maximum safety for your patients.
