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Focus on the classification rules and the GSPR you must meet. ](/terms/mdr?from=eu-mdr-essentials)Mark done 2. 2 [ Regulatory ## EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. Why this term here: The IVD counterpart (2017/746). Focus on the class shift from IVDD and what that means for notified-body involvement. ](/terms/ivdr?from=eu-mdr-essentials)Mark done 3. 3 [ Regulatory ## CE Mark Mandatory European conformity mark for medical devices placed on the EU market. Why this term here: The mark that says you meet EU requirements. Focus on what conformity assessment route your class requires. ](/terms/ce-mark?from=eu-mdr-essentials)Mark done 4. 4 [ Regulatory ## Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. Why this term here: Your independent conformity assessor. Focus on capacity, designation scope, and audit expectations. ](/terms/notified-body?from=eu-mdr-essentials)Mark done 5. 5 [ Regulatory ## EUDAMED European Database on Medical Devices. Why this term here: The EU device database. Focus on which modules are mandatory today and the actor/UDI/certificate flows. ](/terms/eudamed?from=eu-mdr-essentials)Mark done 6. 6 [ Regulatory ## Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. Why this term here: The device identifier. Focus on Basic UDI-DI versus UDI-DI/PI and where each appears in labeling and Eudamed. ](/terms/udi?from=eu-mdr-essentials)Mark done 7. 7 [ Post-Market ## Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. Why this term here: Periodic Safety Update Report. Focus on cadence by class and how it connects to your PMS plan. ](/terms/psur?from=eu-mdr-essentials)Mark done 8. 8 [ Post-Market ## Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. Why this term here: Serious incident and FSCA reporting. Focus on the timelines and the trend-report criteria. ](/terms/vigilance?from=eu-mdr-essentials)Mark done 9. 9 [ Post-Market ## Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. Why this term here: Field Safety Corrective Action. Focus on the FSN wording and how FSCA differs from a US recall. ](/terms/fsca?from=eu-mdr-essentials)Mark done Finished the path? Test yourself with a quiz tailored to these 9 terms. [Take the EU MDR Essentials quiz](/quiz?path=eu-mdr-essentials) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)