General requirements and principles of clinical investigations / recommendations of the MDCG

The MDCG document number MDCG 2023-1 is a guidance document dealing with custom-made devices (CMDs) under the MDR in accordance with Article 2(3) of the EU Medical Device Regulation (MDR).

These exemptions allow health institutions to manufacture, modify or use certain medical devices without complying with the full requirements of the MDR and IVDR, provided certain conditions are met. The guidance provides an interpretation of these conditions and gives practical advice on how to implement them, which are not covered by commercially available devices.

Conditions for the exemption

To qualify for the exemption, health institutions must fulfil several conditions. These include

• In-house manufacture and use: products must be manufactured or modified by the health institution itself and used within the same institution.
• Specific patient needs: The devices must address specific patient needs that are not covered by commercially available devices.
• Quality management system: The health institution must implement a quality management system (QMS) that ensures the safety and performance of the manufactured or modified devices.
• Documentation and traceability: Comprehensive records must be kept of the manufacture, modification and use of the devices to ensure traceability.
• Notification to the competent authorities: The health institution must inform the competent national authorities of the manufacture or modification of the devices and provide additional information on request.

Quality Management System (QMS)

The guide emphasises the importance of a robust quality management system to ensure that manufactured or modified products are safe and effective. Such a QMS should include elements such as risk analysis, validation of manufacturing processes, monitoring and evaluation of product performance and systematic documentation.

Documentation requirements

Health institutions must keep detailed records of the devices manufactured or modified. These records should contain information on the product description, the manufacturing process, the tests and inspections carried out and the results. In addition, the facilities must ensure that the products are clearly identifiable and traceable.

Notification to the competent authorities

Health institutions are obliged to notify the competent national authorities of the manufacture or modification of devices. This notification should include a description of the devices, the intended use, the number of units manufactured or modified and information on the quality management system. If necessary, facilities must provide additional information and documentation to the authorities.

Conclusion

MDCG 2023-1 provides a framework for health institutions wishing to manufacture customised medical devices in accordance with the MDR.

The MDCG is composed of representatives of the European Member States and a representative of the European Commission and draws up recommendations for action without a legally binding character.

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