Icologiq Knowledge · Regulation
EU Medical Device Regulation
The European Union regulation governing medical devices, including requirements for safety, performance, quality systems, clinical evidence and post-market activities.
EU MDR
Also known as:
MDR, Regulation (EU) 2017/745, Medical Device Regulation
At a glance
Type
Regulation
Topic
MedTech
Applies to
MedTech & Medical Devices
Current version
Regulation (EU) 2017/745, consolidated version current 19/07/2026
Status
In force; use the latest consolidated EUR-Lex text for current requirements
Last reviewed
October 9, 2026
Definition
The EU Medical Device Regulation establishes the legal framework for placing and maintaining medical devices on the EU market. It covers manufacturer obligations, conformity assessment, technical documentation, quality systems, vigilance, post-market activities, traceability and other requirements depending on the device and economic-operator role.
Why it matters
The EU Medical Device Regulation matters because manufacturers and other economic operators must be able to demonstrate that medical devices meet applicable safety, performance, documentation, quality-system, vigilance and post-market requirements.
Manufacturers, authorized representatives, importers and distributors have defined responsibilities within the device supply chain.
Economic operators and responsibilities
•
Manufacturers maintain quality-management arrangements and lifecycle Risk Management proportionate to their devices and regulatory responsibilities.
Quality management and Risk Management
•
Clinical evaluation supports demonstration of safety and performance and is maintained as evidence develops across the device lifecycle.
Clinical evaluation and evidence
•
Required technical documentation brings together device description, design/manufacturing information, risk evidence and verification information.
Technical documentation
•
The route to CE marking depends on device class and applicable conformity-assessment procedures, including notified-body involvement where required.
Conformity assessment
•
Manufacturers collect post-market information, manage reportable incidents and use surveillance data to update risk and quality evidence.
Post-market surveillance and vigilance
•
UDI and registration requirements support device identification and regulatory traceability across the market.
Identification and traceability
•
Regulation explained
Core compliance areas under the EU MDR
Regulation (EU) 2017/745 establishes the EU framework for medical devices. Requirements vary by device classification, economic-operator role and conformity route, but manufacturers need an integrated system connecting risk management, clinical evidence, technical documentation, post-market activity and traceability.
The international quality management system standard specifying regulatory-focused requirements for organizations involved in the design, manufacture and lifecycle of medical devices.
ISO 13485
Standard
· MedTech
The international standard defining a systematic process for identifying, evaluating, controlling and monitoring risks associated with medical devices throughout their lifecycle.
ISO 14971
Standard
· MedTech
The structured management of legal, regulatory, certification and internal obligations, including responsibilities, evidence, actions and periodic checks.
Compliance Management
Process
· Compliance
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