MDR (Medical Device Regulation)
Definition
The Medical Device Regulation (MDR), formally known as Regulation (EU) 2017/745, is a comprehensive legislative framework established by the European Union to ensure the safety, performance, and quality of medical devices marketed in the EU. MDR for medical devices replaces the previous Medical Device Directive (MDD) and aims to enhance transparency, traceability, and clinical evaluation of medical products.
MDR applies to a broad range of products, including traditional medical devices, active implantable devices, and certain aesthetic devices. It introduces stricter requirements for clinical evidence, post-market surveillance, and device classification.
Detailed Explanation
Purpose and Importance of MDR for Medical Devices
The MDR medical device regulation was introduced to strengthen the existing regulatory framework and to address the technological advancements and safety concerns that emerged under the previous directives. Its primary goals are to:
- Ensure a high level of health and safety protection for patients and users
- Improve transparency through better labeling and public access to information
- Enhance traceability of medical devices throughout the supply chain
Key Changes Introduced by MDR
MDR introduces several significant changes compared to the previous MDD, including:
- Expanded Scope: Includes non-medical devices with similar characteristics and risk profiles (e.g., colored contact lenses, cosmetic implants).
- Stricter Classification Rules: Reclassifies certain devices to higher risk classes, requiring more rigorous conformity assessment.
- Unique Device Identification (UDI): Improves traceability and recall processes.
- Clinical Evaluation Requirements: Mandates more robust clinical data and post-market clinical follow-up (PMCF).
- Post-Market Surveillance (PMS): Requires manufacturers to actively monitor device performance and safety once on the market.
- EUDAMED Database: Centralizes information on devices, manufacturers, and clinical investigations, enhancing transparency.
Device Classification Under MDR
Medical devices under MDR are classified into four risk-based categories:
- Class I: Low risk (e.g., bandages, stethoscopes)
- Class IIa: Medium risk (e.g., dental fillings, syringes)
- Class IIb: Higher risk (e.g., ventilators, infusion pumps)
- Class III: Highest risk (e.g., heart valves, implantable defibrillators)
Each class determines the level of scrutiny and involvement of a Notified Body in the conformity assessment process.
Clinical Evaluation and Performance
Under MDR, clinical evaluation is a continuous process involving:
- Critical evaluation of relevant scientific literature
- Assessment of clinical investigations
- Post-market clinical follow-up (PMCF)
Manufacturers must demonstrate that their devices achieve intended benefits and maintain acceptable risk profiles through real-world data collection and analysis.
Post-Market Surveillance (PMS)
MDR mandates a proactive PMS system, including:
- Systematic collection and analysis of post-market data
- Risk-benefit reassessment based on new information
- Regular updates to the clinical evaluation and technical documentation
Manufacturers must prepare a Periodic Safety Update Report (PSUR) for Class IIa and higher devices.
Role of Economic Operators
MDR defines clear responsibilities for all economic operators in the medical device supply chain:
- Manufacturer: Ensures compliance and maintains technical documentation
- Authorized Representative: Acts on behalf of non-EU manufacturers
- Importer: Verifies compliance before placing devices on the EU market
- Distributor: Ensures storage and transport conditions are maintained
Transition Period and Implementation
The MDR entered into force on May 25, 2017, with a transition period ending on May 26, 2021. However, due to the COVID-19 pandemic and implementation challenges, certain legacy devices are allowed continued market access under specific conditions until 2028, provided they comply with extended transitional provisions.
