EUDAMED

‍EUDAMED is the European database established for medical devices, playing a key role in compliance with the European Union's regulatory frameworks, specifically the Medical Device Regulation (EU MDR).

The requirement to register in EUDAMED is a critical step in the MDD to MDR transition process, which is still being finalized by many medical device manufacturers. Compliance with the MDR ensures devices are safe and available for sale in the European Union (EU) and European Economic Area (EEA).

The MDD to MDR transition process is the mandatory regulatory shift required for medical device manufacturers to migrate their certifications from the defunct European Union (EU) Medical Device Directive (MDD) to the current, stricter EU Medical Device Regulation (EU MDR 2017/745).This process is critical because the EU MDR replaced the MDD, imposing stricter requirements on manufacturers, suppliers, and distributors, and MDD certificates are ** no longer sufficient for market access** in the EU/EEA

The EU MDR (Medical Device Regulation) mandates a strict framework for device conformity and registration in Europe, and failing to meet the deadlines or requirements—including registration in EUDAMED—can severely impact a manufacturer's ability to operate in the European market.

Here is a breakdown of EUDAMED's function and significance:

Role in the EU MDR Compliance

EUDAMED is essential for manufacturers seeking certification under the EU Medical Device Regulation (EU Regulation 2017/745) (EU MDR).

• Manufacturer Registration: As part of fulfilling the essential obligations of a medical device manufacturer under the EU MDR, manufacturers must register their organization in EUDAMED.
• Unique Device Identification (UDI) Traceability: EUDAMED is central to the EU's traceability requirements:
  • The Basic UDI-DI (Unique Device Identifier—Device Identifier) is used in EUDAMED.
  • Once EUDAMED becomes fully operational, all UDIs will need to be uploaded to the database.

Here is more information regarding the EU MDR requirements and the regulatory consequences of failing to register products on time.

Consequences of Failing to Register Products in Time (EU Market Access)

The EU MDR (Regulation 2017/745) replaced the previous Medical Device Directive (MDD), and compliance is mandatory to sell products on the EU market.

If a manufacturer of an eligible device fails to meet the required deadlines for submitting documentation and implementing a compliant Quality Management System (QMS), the primary consequence is the loss of market access in the European Union (EU) and European Economic Area (EEA).

Loss of Transition Eligibility

For devices previously certified under the MDD, manufacturers could qualify for extended transition deadlines, but this required timely action:

• Application Deadline: The extended transition periods are only valid if the manufacturer submitted an MDR application by May 26, 2024.
• Validity of Old Certificates: The original CE certificates issued under the MDD are no longer sufficient for market access.
• Loss of Extension: If the manufacturer failed to submit the MDR application by the May 2024 deadline, they are generally ineligible for the extended transition periods (which run until December 31, 2027, for Class III and Class IIb implantable devices, and until December 31, 2028, for other eligible devices).
• New Market Entry Status: The MDR treats certification as a new market entry, even for devices that have been on the market for years. Without timely certification by a Notified Body, the product cannot legally be sold.

Consequences of Non-Compliance During Transition

Even if a manufacturer meets the MDR application deadlines, failure to maintain compliance during the transition period carries risks:

• Significant Changes: Manufacturers must ensure no significant changes are made to their devices (including design, intended use, or modification) that could void their transitional eligibility. Any modification must be assessed in terms of safety and performance.
• PMS Implementation: Manufacturers must fully implement the updated Post-Market Surveillance (PMS) requirements even if their existing certification remains under the old MDD. The QMS must include specific procedures for change management to address changes to the design or harmonized standards in a timely manner.
• Vigilance Reporting: MDR mandates timely reporting of device-related risks through vigilance reporting (Article 87).

Consequences of Failing to Register/List (U.S. FDA Context)

While EUDAMED and MDR apply to the EU, U.S. FDA regulations impose similar severe penalties for non-compliance with mandatory registration and listing requirements (FDA 21 CFR Part 807) and adherence to device requirements.

Failure to Register/List (FDA Requirements)

Manufacturers and initial importers operating in the U.S. must register their establishment and list their devices with the FDA:

• Loss of Active Status: Failure to submit any of the required information on time (initial registration/listing, annual updates, or change updates) will put the establishment in a "failed to register" or "failed to list" status.
• Website Removal: The establishment will not be considered active and the registration and device listing information may not appear on the FDA Web site until the required information is submitted and processed.
• Import Prohibition: For foreign establishments, no device may be imported or offered for import into the United States unless it is the subject of a device listing and is manufactured at a registered foreign establishment (except for devices imported for investigational use under Part 812).

Regulatory Enforcement Action

Failure to comply with any applicable regulation makes a device subject to regulatory enforcement:

• Adulteration and Misbranding: Failure to comply with QSR requirements renders a device adulterated. A device may also be considered misbranded if the manufacturer or distributor fails to comply with certain requirements, such as device tracking.
• Seizure and Detention: Devices deemed adulterated or misbranded are subject to regulatory action. This can include administrative detention, which is intended to protect the public by preventing the distribution or use of devices until the FDA determines the appropriate legal action. Devices under detention may not be used, moved, altered, or tampered with in any manner during the detention period.
• Prohibited Acts: Failure to comply with mandatory Postmarket Surveillance orders (which are typically issued for high-risk, tracked devices) constitutes a prohibited act and misbrands the device. Persons who commit prohibited acts can be enjoined, required to pay civil money penalties, or prosecuted.
• Foreign Facility Refusal: If a foreign manufacturer offering devices for import refuses to permit an FDA inspection to determine QMS compliance, it suggests the device is adulterated and may lead to refusal of admission into the U.S..
• Vigilance Penalties: Failure to submit MDR reports on time (e.g., manufacturers must report deaths, serious injuries, or certain malfunctions to the FDA within 30 calendar days of becoming aware of the event, or within 5 working days if remedial action is necessary to prevent substantial harm) can lead to non-compliance penalties.

‍