MDR and IVDR (Medical Device Regulation & In Vitro Diagnostic Regulation)
Definition
MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are European Union regulations that govern the safety, performance, and marketing of medical devices and in vitro diagnostic medical devices within the EU market. MDR replaces the former Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD), while IVDR replaces the In Vitro Diagnostic Medical Devices Directive (IVDD). These regulations aim to ensure a high standard of quality and safety for medical products and to enhance transparency and traceability throughout the supply chain.
Detailed Explanation
Purpose and Scope of MDR and IVDR
The MDR and IVDR were introduced to strengthen the regulatory framework for medical devices and in vitro diagnostics in Europe. They address technological advancements, close regulatory gaps, and improve the overall safety and performance of devices placed on the market.
Key objectives include:
- Enhancing patient safety and product performance through stricter pre-market and post-market requirements
- Improving transparency with a centralized EU database (EUDAMED)
- Strengthening the role of Notified Bodies and harmonizing conformity assessments
- Ensuring better traceability of devices via Unique Device Identification (UDI)
Key Differences Between MDR and IVDR
While both regulations share many structural similarities, their scopes differ significantly:
| Aspect | MDR | IVDR |
|---|---|---|
| Applies To | Medical devices (e.g., implants, surgical instruments) | In vitro diagnostic devices (e.g., blood tests, genetic tests) |
| Regulation Number | EU 2017/745 | EU 2017/746 |
| Risk Classification | Class I, IIa, IIb, III | Class A, B, C, D (new risk-based classification) |
| Notified Body Involvement | Required for most devices except low-risk Class I | Required for most devices (approx. 80% vs. 20% under IVDD) |
| Implementation Date | 26 May 2021 | 26 May 2022 |
Impact on Manufacturers and Notified Bodies
Both MDR and IVDR impose significant regulatory burdens on manufacturers and Notified Bodies. These include:
- More rigorous clinical evaluation and performance studies
- Expanded technical documentation and post-market surveillance
- Greater scrutiny by Notified Bodies before CE marking
- Re-certification of legacy devices under new rules
For instance, under IVDR, many diagnostic devices that were previously self-certified now require Notified Body oversight, leading to increased demand and capacity challenges.
Key Compliance Requirements
- UDI System: Both MDR and IVDR mandate a Unique Device Identifier for traceability.
- EUDAMED Registration: Devices and economic operators must be registered in the centralized EU database.
- Post-Market Surveillance (PMS): Continuous monitoring of product performance and safety.
- Clinical Evaluation/Performance Evaluation: Required to demonstrate safety and efficacy (MDR) or performance (IVDR).
Examples and Real-World Application
A company manufacturing blood glucose test strips (an IVD) previously self-certified under the IVDD must now undergo a conformity assessment with a Notified Body under IVDR. Similarly, a manufacturer of orthopedic implants must update clinical data and technical documentation to comply with MDR.
These changes have led many companies to reassess their product portfolios, invest in regulatory affairs teams, and seek early engagement with Notified Bodies to avoid market disruption.
