European Union
EU MDR (Regulation (EU) 2017/745): European Union Medical Device Regulation
The EU Medical Device Regulation sets the rules for placing medical devices on the market in the European Union. It is directly applicable in every member state and asks more of manufacturers than the directives it replaced, especially on clinical evidence, post-market surveillance and notified body oversight.
At a Glance
- Regulation
- EU MDR (Regulation (EU) 2017/745)
- Subject
- European Union Medical Device Regulation
- Group
- European Union
- Industries
- 7 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
The MDR covers medical devices and their accessories, plus certain groups of products without an intended medical purpose that it brings into scope. Devices are classified into class I, IIa, IIb and III using the regulation's classification rules, and the class decides the conformity assessment route. Apart from most class I devices, conformity assessment involves a notified body, which audits the QMS and reviews technical documentation before issuing a certificate.
Manufacturers must show that each device meets the general safety and performance requirements (GSPR) in Annex I, supported by technical documentation and a clinical evaluation based on sufficient clinical evidence. The regulation requires a QMS, a risk management system, and a post-market surveillance system that feeds back into the clinical evaluation and risk management, including post-market clinical follow-up (PMCF) where applicable. Manufacturers must report serious incidents and field safety corrective actions through the vigilance system, and must have a person responsible for regulatory compliance (PRRC) available.
The MDR also brings UDI to the EU and relies on EUDAMED, the European database for devices, economic operators, certificates, vigilance and clinical investigations. Notified bodies conduct initial audits, surveillance audits and unannounced audits, and the regulation requires unannounced audits at least once every five years. Non-EU manufacturers need an authorized representative in the EU.
Who It Applies To
- Manufacturers placing medical devices or accessories on the EU market, wherever they are located
- Authorized representatives, importers and distributors, each with their own obligations
- US manufacturers expanding into the EU who need a notified body and technical documentation in MDR format
- Makers of certain products without an intended medical purpose that the regulation brings into scope
What Auditors Check
Technical Documentation
Notified bodies review whether the technical documentation is complete, current and demonstrates conformity with the GSPR, with clear traceability to evidence.
Clinical Evaluation
Whether the clinical evidence is sufficient for the device's claims and risk class, and whether the clinical evaluation is updated with post-market data.
Post-Market Surveillance and PMCF
Whether the PMS plan is followed, data are actually analyzed, and conclusions flow into risk management, clinical evaluation and the required PMS reports.
Vigilance
How serious incidents and field safety corrective actions are identified, assessed and reported to competent authorities.
QMS and Risk Management
Whether the QMS covers the MDR's specific requirements on top of ISO 13485, and whether risk management runs across the device's lifecycle.
PRRC and Economic Operators
Whether a qualified PRRC is designated, and whether obligations of the authorized representative, importers and distributors are defined.
UDI and EUDAMED
Whether UDI is assigned and applied as required, and whether registration data are maintained.
Related Services
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
ISO 13485 Certification Readiness
Prepare your QMS, records and people for a certification body's Stage 1 and Stage 2 audits.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference EU MDR (Regulation (EU) 2017/745)
Questions
Does ISO 13485 certification satisfy the MDR's QMS requirements?
It is a strong foundation, since notified bodies generally assess the QMS with ISO 13485 in mind, but the MDR adds requirements of its own. Examples include post-market surveillance and PMCF, vigilance, the PRRC role and UDI. A gap assessment against the regulation itself shows what remains.
Will our notified body show up unannounced?
Yes, the MDR requires notified bodies to conduct unannounced audits at least once every five years, which may include the manufacturer and critical suppliers or subcontractors. Being ready for one means keeping records current all the time, not just before a scheduled audit.
We are a US manufacturer. What changes for us under the MDR?
You need an EU authorized representative, a notified body for most device classes, technical documentation and clinical evaluation in the form the MDR expects, and EU post-market surveillance and vigilance processes. Much of your QMS will carry over, but the documentation and post-market sides usually need the most work.
How does QMSAdvisor help with MDR readiness?
We start with an AI-assisted first pass over your existing QMS and technical documentation, then an advisor reviews the gaps against the MDR. Findings go into an action plan with owners, due dates and evidence requirements. The certification decision always rests with your notified body.
EU MDR (Regulation (EU) 2017/745)
Check Your Quality System Against EU MDR (Regulation (EU) 2017/745)
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
