# EU Medical Device Regulation (EU MDR) | Botable Glossary

https://www.botable.ai/glossary/eu-medical-device-regulation-eu-mdr

> Informative glossary/summary on a company website: useful as a concise reference for regulatory concepts and requirements but not an official legal text. When using for compliance work, cross-check with the actual regulation (EU Regulation 2017/745) and official EU guidance or notified bodies.

## Summary

This glossary entry defines the EU Medical Device Regulation (EU MDR, EU Regulation 2017/745) and summarizes its scope, key manufacturer obligations (QMS, PRRC, registration in EUDAMED), UDI and traceability requirements, strengthened post-market surveillance and CAPA obligations, and conformity assessment involving Notified Bodies. It notes transition timelines and that MDR replaced the MDD.

## Audience

Medical device manufacturers and regulatory/quality professionals

## Prompts this page answers

- What are the main manufacturer obligations under the EU MDR (EU Regulation 2017/745)?
- What are the UDI requirements under EU MDR and what are UDI-DI / UDI-PI used for?
- Which devices had extended transition deadlines under the EU MDR and what are those dates?
- What Quality Management System elements does EU MDR require (standards and annexes referenced)?
- When is Notified Body involvement required under EU MDR and what is the conformity assessment outcome?

## Purpose

Explain and summarize the main requirements and implications of the EU Medical Device Regulation for medical device manufacturers and related stakeholders.

## Highlights

- EU MDR is EU Regulation 2017/745 and replaced the Medical Device Directive (MDD).
- MDR became fully applicable in May 2021; transition application deadlines passed in May 2024, with extended transition deadlines for certain devices (Class III and Class IIb implantable devices until 2027-12-31; other eligible devices until 2028-12-31).
- Manufacturers must implement a Quality Management System aligned with EN ISO 13485:2016 and address risk management, clinical evaluation, and UDI verification.
- Manufacturers must assign a Person Responsible for Regulatory Compliance (PRRC) and register in EUDAMED.
- UDI requirements and enhanced Post-Market Surveillance (PMS) and CAPA systems are mandatory; Notified Body involvement is required for many device classes.

## How to cite

Botable Glossary — "EU Medical Device Regulation (EU MDR)"; https://www.botable.ai/glossary/eu-medical-device-regulation-eu-mdr

## Publisher



## Topics

- EU MDR
- EU Regulation 2017/745
- EUDAMED
- Unique Device Identification (UDI)
- Quality Management System EN ISO 13485:2016
- Post-Market Surveillance (PMS)
- Notified Bodies
- PRRC

## Key entities

- **EU Medical Device Regulation (EU MDR)** (other): EU Regulation 2017/745 — primary regulatory framework for medical devices in the EU/EEA (as stated on the page). — https://www.botable.ai/glossary/eu-medical-device-regulation-eu-mdr
- **EU Regulation 2017/745** (other): Legal identifier given for the EU MDR on the page.
- **Medical Device Directive (MDD)** (other): The prior directive replaced by the MDR, referenced on the page.
- **EUDAMED** (other): European database for medical devices; manufacturers must register (page links to glossary term). — /glossary/eudamed
- **EN ISO 13485:2016** (other): QMS standard referenced as corresponding to MDR QMS requirements.
- **UDI (Unique Device Identification)** (other): Device identification and traceability system; page describes Basic UDI-DI, UDI-DI and UDI-PI. — /glossary/unique-device-identifier-udi
- **PRRC (Person Responsible for Regulatory Compliance)** (other): Role manufacturers must assign under the MDR (mentioned on page).
- **Notified Bodies** (other): EU-authorized organizations that assess conformity for many device classes (described on page).

## Metadata

- Type: article