The European Union Medical Device Regulation (EU MDR) came into force on May 26, 2021, and has significantly impacted the medical device industry. As a sponsor of medical devices, it’s crucial to understand the new requirements and implement them accordingly. In this blog, we will outline ten essential things that sponsors should know about the EU MDR.
- Scope and classification of devices:
The EU MDR covers a wide range of medical devices, including implantable devices, in-vitro diagnostic devices, and software. The regulation also introduces new classification rules, which determine the risk level of the device and the applicable regulatory requirements.
- Unique Device Identification (UDI):
The EU MDR requires each medical device to have a Unique Device Identification (UDI) that will be stored in the European database on medical devices (EUDAMED). The UDI system will enhance traceability and improve the overall safety of medical devices.
- Notified Bodies:
Under the EU MDR, the role of Notified Bodies has been strengthened. These organizations are responsible for assessing and certifying the conformity of medical devices with the regulation. Sponsors should ensure that their Notified Body is designated under the EU MDR to avoid potential delays in the certification process.
- Technical documentation:
Sponsors are required to maintain up-to-date technical documentation, demonstrating the compliance of their devices with the EU MDR. This includes a comprehensive risk management system, clinical evaluation reports, and post-market surveillance documentation.
- Clinical evaluation:
The EU MDR places a stronger emphasis on the clinical evaluation of medical devices. Sponsors must provide robust clinical data to demonstrate the safety and performance of their devices. The data can come from clinical investigations, literature reviews, or a combination of both.
- Post-market surveillance (PMS):
The regulation requires sponsors to implement a proactive post-market surveillance system. This includes monitoring the performance of devices on the market, reporting any incidents or trends, and updating the risk management and clinical evaluation documentation accordingly.
- Vigilance reporting:
Sponsors must report serious incidents and field safety corrective actions to the relevant Competent Authority within specific timeframes, as outlined in the EU MDR. This also applies to incidents that occur outside of the EU if the device is available in the European market.
- Economic operators:
The EU MDR introduces new responsibilities for economic operators, such as manufacturers, authorized representatives, importers, and distributors. Sponsors must ensure that these entities comply with their respective obligations, as non-compliance can result in penalties and delays in bringing products to the market.
- Person Responsible for Regulatory Compliance (PRRC):
Each medical device manufacturer or authorized representative must appoint a Person Responsible for Regulatory Compliance (PRRC). This person should have the necessary expertise in the field of medical devices and be responsible for ensuring compliance with the EU MDR requirements.
- Transition period and legacy devices:
Although the EU MDR came into force on May 26, 2021, a transition period was granted for certain medical devices. Manufacturers have until May 26, 2024, to update their technical documentation and bring these “legacy devices” into compliance with the regulation.
Conclusion:
The EU MDR has introduced significant changes to the medical device industry. As a sponsor, it’s essential to be aware of these changes and ensure that your organization complies with the new requirements. By following these ten essential points, you’ll be well on your way to navigating the complex landscape of EU MDR compliance.
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