EUDAMED Terminology: Regulatory Vocabulary Guide

The Fundamentals of EUDAMED

EUDAMED (European Database on Medical Devices): European database on medical devices, created by the European Commission to centralise information relating to medical devices and improve transparency and coordination within the European Union.

EUDAMED Modules

EUDAMED is structured into six interconnected modules, each with its specific terminology:

• ACT Module (Actors Module): Module for actors, allowing economic operators to register.
• UDI/DEV Module (UDI/Devices Module): Module for device registration and UDI database.
• NB/CRF Module (Notified Bodies & Certificates Module): Module for notified bodies and certificates.
• CI/PS Module (Clinical Investigations & Performance Studies Module): Module for clinical investigations and performance studies.
• VGL Module (Vigilance Module): Module for vigilance and post-market surveillance.
• MSU Module (Market Surveillance Module): Module for market surveillance.

Terminology Related to European Regulations

Regulations

• MDR (Medical Device Regulation): Regulation (EU) 2017/745 on medical devices, replacing directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD).
• IVDR (In Vitro Diagnostic Regulation): Regulation (EU) 2017/746 on in vitro diagnostic medical devices, replacing directive 98/79/EC (IVDD).

Previous Directives

• MDD (Medical Device Directive): Directive 93/42/EEC concerning medical devices and Directive 90/385/EEC concerning active implantable medical devices, replaced by the MDR.
• IVDD (In Vitro Diagnostic Device Directive): Directive 98/79/EC on in vitro diagnostic medical devices, replaced by the IVDR.

Terminology Related to Device Identification

UDI Identifiers

• UDI (Unique Device Identification): System for unique identification of medical devices, composed of two parts:
  • UDI-DI (UDI Device Identifier): Unique identifier specific to a device model.
  • UDI-PI (UDI Production Identifier): Variable identifier including information such as lot number, expiry date or serial number.
• Basic UDI-DI: Primary identifier grouping a family of devices with the same intended purpose and essential characteristics. It does not appear on the label but serves as the access key in EUDAMED.
• EUDAMED-DI: Temporary identifier assigned to legacy devices if no UDI-DI is available.
• UoU (Unit of Use UDI-DI): Identifier for the unit of use, used when the UDI is not labelled at the device’s unit-of-use level.

Issuing Entities

• Issuing Entity: Organisation designated to assign UDIs in accordance with the regulation. The four recognised entities are:
  • GS1: International organisation developing supply chain standards.
  • HIBCC (Health Industry Business Communications Council): Organisation providing standards for health product identification.
  • ICCBBA: Organisation managing the ISBT 128 system for biological products.
  • IFA (Informationsstelle für Arzneispezialitäten): Organisation providing coding systems for medicines and medical devices.

Terminology Related to Economic Operators

Types of Actors

• Manufacturer: Natural or legal person who manufactures or refurbishes a device, or has a device designed, manufactured or refurbished, and markets it under their name or trademark.
• Authorised Representative: Natural or legal person established in the EU who has received a written mandate from a manufacturer outside the EU to act on their behalf.
• Importer: Natural or legal person established in the EU who places a device from a third country on the EU market.
• Distributor: Natural or legal person in the supply chain who makes a device available on the market, up to placing it into service.
• SPPP (System and Procedure Pack Producer): Manufacturer of systems and procedure packs, who combines CE-marked devices with other devices or products.

Actor Identifiers

• SRN (Single Registration Number): Unique registration number assigned to economic operators registered in EUDAMED.

Actor ID: Alternative name for the SRN in the EUDAMED Actor module.Terminology Related to Medical Devices

• Actor ID: Alternative name for the SRN in the EUDAMED Actor module.Terminology Related to Medical Devices

Classification

• Class I, IIa, IIb, III: Risk classes for medical devices under MDR, where Class I represents the lowest risk and Class III the highest risk. Class I devices, except for specific exceptions, only require an EU Declaration of Conformity from the manufacturer (self-declaration). All other classes require the involvement of a Notified Body and the issuance of a Certificate of Conformity.
• Class A, B, C, D: Risk classes for in vitro diagnostic devices under IVDR, where Class A represents the lowest risk and Class D the highest risk. Class A devices only require a self-declaration by the manufacturer.
• Ir (Special case) : Class I reusable surgical devices. A Notified Body is required for these specific aspects.
• Is (Special case): Class I sterile devices. A Notified Body is required for these specific aspects.
• Im (Special case): Class I measuring devices. ****A Notified Body is required for these specific aspects.

Specific Device Types

• Legacy Device: Device compliant with the former directives (MDD, AIMDD, IVDD) benefiting from the transition periods provided by MDR and IVDR.
• System: Combination of products, packaged together or separately, intended to be connected or combined to achieve a specific medical purpose.
• Procedure Pack: Combination of products packaged together and placed on the market to be used for a specific medical purpose.
• Configurable Device: Device composed of several components the manufacturer allows to be assembled in multiple ways.
• SPP (System and Procedure Pack): A specific type of configurable device, for which the manufacturer defines the possible configurations in the technical documentation, and each configuration complies with the general safety and performance requirements.
• IVD Kit: Set of components packaged together and intended for use to perform a specific in vitro diagnostic examination.

Terminology Related to Vigilance and Surveillance

• FSCA (Field Safety Corrective Action): Corrective safety action implemented by a manufacturer to reduce the risk of a serious incident related to a medical device already on the market.
• FSN (Field Safety Notice): Communication addressed to customers and/or users regarding an FSCA.
• PSUR (Periodic Safety Update Report): Updated periodic safety report that manufacturers must submit for Class IIa, IIb and III devices (MDR) or Class D devices (IVDR).
• SSCP (Summary of Safety and Clinical Performance): Summary of safety and clinical performance characteristics, a document intended for the public for implantable and Class III devices.

Technical Terminology for Interfaces and Data Exchanges

• M2M (Machine to Machine): An automated, secure, and bidirectional architecture for the exchange of structured data, far more powerful than a simple manual or semi-automated XML file upload.XML (eXtensible Markup Language): The file format used for data exchanges with EUDAMED. It is based on the AS4 protocol and uses an Access Point (a certified technical gateway).Data exchanges are therefore asynchronous; this prevents system blocking but means that sending and receiving are not immediate.
• XML (eXtensible Markup Language): File format used for data exchanges with EUDAMED.

Principles and Methodologies Related to Data Integrity

• ALCOA+: Acronym defining the fundamental principles of data integrity:
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • +: Complete, Consistent, Enduring, Available
• Data Integrity: Principle ensuring that data are complete, consistent and accurate throughout their lifecycle.

Conclusion

Mastery of this EUDAMED-specific terminology is an essential prerequisite for all professionals involved in the regulatory compliance of medical devices in Europe. This lexicon will help you navigate more effectively the complex requirements of MDR and IVDR, thereby facilitating your path to compliance.