Medical Devices Regulation (MDR) 2017/745 - Identification, traceability See more https://www.aretezoe.com/medical-devices

1. IDENTIFICATION
TRACEABILITY
UDI carrier mandatory from May 2021
PAGE 1
Identification of medical devices
within supply chain

2. UDI System
 Appropriate level of traceability of medical
devices within supply chain
 BASIC UDI-DI identifies device model
 UDI-DI identifies model and serves as access
key to UDI database
 UDI-PI identifies the unit of device production
 Internationally recognized nomenclature
 The obligation for UDI assignment applies as
of 26 May 2020 for medical devices
 EUDAMED’s launch will be done together for
medical and in-vitro devices in May 2022.
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https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics

3. PAGE 3
https://ec.europa.eu/docsroom/documents/36664/attachments/1/translations/en/renditions/native

4. EUDAMED
The new EUDAMED database will include:
 Registration of devices
 Unique Device Identifiers
 Registration of economic operators (except for
distributors)
 Notified bodies, Certificates
 Clinical investigations
 Vigilance, Post-market surveillance
 Market surveillance (inspections, non-
compliance, health protection measures)
PAGE 4
Article 29, 30, 31
Part A of Annex VI
https://ec.europa.eu/docsroom/documents/33862/attachments/1/translations/en/renditions/native
 Functional specifications defined by EC and
Medical Device Coordination Group (MDCG)
 Information accessible to general public
 information on UDIs facilitates traceability
 Information on clinical investigations
 Reporting serious incidents
 Field Safety Corrective Actions
 EUDAMED will serve EU/EEA authorities to
cooperate and exchange information

5. PAGE 5

6. PAGE 6
REGISTRATION OF DEVICES
 Before placing a device on the
market, manufacturers shall assign
Basic UDI-DI
 Whoever places procedure packs
on the market shall assign Basic
UDI-DI
 Enter/verify information in
Eudamed

7. Registration of
economic operators
 Manufacturers, Authorized Representatives and Importers must register in EUDAMED
 Competent Authority obtains and issues a Single Registration Number (SRN)
 The manufacturer shall use SRN when applying to Notified Body for Conformity Assessment
 Any changes shall be reported within 1 week
 Semi-annual confirmation of correctness of data
 Competent authority verifies data from economic subjects
 Information submitted to EUDAMED shall be available to the public
 Competent authorities can use information from EUDAMED to collect fees
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Article 31
Part A of Annex VI

8. Summary of Safety and Clinical Performance
 Implantable and Class III devices
 Summary must be clear to intended user
 Draft shall be submitted to Notified body
as part of Conformity Assessment
 Available via EUDAMED after validation
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Article 32
Part A of Annex VI
CONTENT
 Identification, Basic UDI-DI, SRN
 Intended purpose, indications
 Contraindications
 Target populations
 Description of the device
 Diagnostic and therapeutic alternatives
 Reference to any harmonized standards
 Summary of clinical evaluation
 Suggested profile and training for users
 Residual risks, undesirable effects, warnings, precautions