Medical Device Regulation (MDR)
The EU regulation governing the placing on the market of medical devices, applying since May 2021 in place of the Medical Devices Directive. It raises the bar on clinical evidence, post-market surveillance, unique device identification (UDI), and the role of notified bodies, and requires a compliant quality management system throughout the device lifecycle.
What this does not cover
stated in the document's own scope- Covers medical devices; in vitro diagnostic devices are governed by the parallel Regulation (EU) 2017/746 (IVDR).
- Sets the regulatory framework, with the detailed QMS expectations supplied by EN ISO 13485 rather than the regulation text itself.
- Governs devices placed on the EU market; equivalent US-market access follows the separate FDA device framework.
- Applies to products meeting the device definition or listed in Annex XVI, not to medicinal products, which fall under the medicines legislation.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), governs the placing on the EU market and putting into service of medical devices. It replaced the earlier Medical Devices Directive and the Active Implantable Medical Devices Directive with a single, more demanding regulation. The MDR covers device classification and conformity assessment, the role and oversight of notified bodies, clinical evaluation and clinical investigation, post-market surveillance and vigilance, unique device identification (UDI), the EUDAMED database, and the obligation on manufacturers to operate a quality management system covering the whole device lifecycle. Its scope also reaches certain products without an intended medical purpose listed in Annex XVI.
Scope & applicability
Medical devices placed on the EU market — from classification and conformity assessment through clinical evaluation, UDI, and post-market surveillance.
Legal basis & how it acquires force
The MDR is a Regulation, so it applies directly across the EU/EEA without national transposition, replacing the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. It entered into force in 2017 and became fully applicable on 26 May 2021 after a one-year deferral, with staggered transitional provisions for legacy certificates that have since been extended. Meeting the regulation is the condition of CE-marking a device; it establishes obligations for manufacturers, authorised representatives, importers and distributors.
Document structure
| Part | Covers |
|---|---|
| Scope, definitions and classification | Devices covered, Annex XVI products, and the risk-based classification rules |
| Economic operators and notified bodies | Obligations of manufacturers, importers and distributors, and designation of notified bodies |
| Conformity assessment and QMS | Conformity-assessment routes, the required quality management system, and technical documentation |
| Clinical evaluation and investigation | Clinical evidence requirements and the conduct of clinical investigations |
| Identification and traceability | The UDI system and registration in the EUDAMED database |
| Post-market surveillance and vigilance | Post-market surveillance, post-market clinical follow-up, and incident reporting |
Key requirements
- Determine device classification and the correct conformity-assessment route
- Maintain clinical evaluation and post-market clinical follow-up evidence
- Operate post-market surveillance and vigilance/incident reporting
- Assign UDI and register devices/actors in EUDAMED
- Maintain an ISO 13485-aligned quality management system
Implementation tips
- Treat clinical evidence and PMS as the two areas MDR toughened most versus the MDD
- Use ISO 13485 as the QMS backbone auditors and notified bodies expect
- Plan UDI and EUDAMED data early — they are a distinct, ongoing compliance surface
Revision notes
Applying since 26 May 2021 (transition provisions extended by Regulation (EU) 2023/607), replacing Directive 93/42/EEC with stronger clinical, PMS, and traceability requirements.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
In practice the quality-management-system requirement is met through EN ISO 13485, the international QMS standard for medical devices, and clinical and risk requirements draw on standards such as ISO 14971 for risk management. The MDR sits alongside the In Vitro Diagnostic Regulation (EU) 2017/746 for IVDs, and reflects the globally converging device expectations promoted through IMDRF, though CE-marking under the MDR is distinct from the US FDA clearance/approval pathways.
Regulation (EU) 2017/745: frequently asked questions
Quick answers to common questions about Regulation (EU) 2017/745.
When did the EU Medical Device Regulation become fully applicable?
Regulation (EU) 2017/745 became fully applicable on 26 May 2021, after a one-year deferral from its original date. Transitional provisions for legacy certificates issued under the old directives have since been extended.
What did the MDR replace?
It replaced two earlier directives — the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC — with a single directly applicable regulation that raised requirements for clinical evidence, post-market surveillance and traceability.
Does the MDR require ISO 13485?
The MDR requires manufacturers to operate a quality management system across the device lifecycle. It does not name a standard, but conformity to EN ISO 13485 is the practical route most manufacturers use to demonstrate a compliant QMS.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.