MDD to MDR Transition for Medical Devices

The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) marks a significant change in the regulatory framework for medical devices in the European Union (EU). The MDR came into full effect on May 26, 2021, replacing the MDD and introducing more stringent requirements for the marketing and oversight of medical devices.

Here are some key points to consider regarding the transition from MDD to MDR for medical devices:

1. Scope and Classification: The MDR has a broader scope and includes a wider range of medical devices than the MDD. It introduces new classification rules, which might result in the reclassification of some devices.

2. Conformity Assessment: The MDR emphasizes a risk-based approach to conformity assessment. It introduces stricter requirements for clinical evidence and post-market surveillance. Manufacturers need to provide more comprehensive data on safety, performance, and clinical benefit.

3. Unique Device Identification (UDI): The MDR mandates the use of Unique Device Identifiers (UDIs) for better traceability of devices throughout their lifecycle. UDIs provide information about the device's identity, origin, and production history.

4. Post-Market Surveillance: The MDR places greater emphasis on post-market surveillance and vigilance. Manufacturers are required to actively monitor the performance of their devices on the market and report any incidents or safety concerns.

5. Economic Operators: The MDR introduces new roles for economic operators in the supply chain, including importers and distributors. These entities have specific responsibilities related to device oversight and reporting.

6. Clinical Data Requirements: The MDR sets higher standards for clinical data and requires more extensive clinical evaluation for devices, especially for high-risk devices. Clinical data must support the device's safety and performance claims.

7. Notified Bodies: Notified Bodies play a crucial role in the conformity assessment process. The MDR requires stricter criteria for designation and oversight of Notified Bodies to ensure consistency and reliability in the assessment process.

8. Transitional Period: There was a transition period for manufacturers to comply with the MDR. Devices certified under the MDD could continue to be placed on the market until May 26, 2024, if the MDD certificate remained valid. However, for new devices, the MDR requirements are applied immediately after implementation.

9. Legacy Devices: After the transition period, devices that were certified under the MDD and placed on the market could still be used, provided they continue to meet their intended purpose and do not compromise patient safety. However, any modifications to these devices may trigger the need for MDR compliance.

It's important for manufacturers, importers, distributors, and other stakeholders in the medical device industry to understand the new requirements outlined in the MDR and ensure compliance to continue marketing and using medical devices in the EU market. The transition involves comprehensive changes, including adjustments to processes, documentation, and quality management systems to align with the new regulation. It's recommended to consult with legal experts and regulatory consultants to navigate the transition successfully.

IZiel team of specialists and quality professionals look forward to support more medical device companies to file their devices under the MDR 2017/745.