EU Medical Device Regulation
(MDR 2017/745)
Navigate EU MDR with confidence. We help medical device companies achieve EU MDR compliance and access the European market with expert guidance and end-to-end support.
Regulatory Expertise
In-depth knowledge of EU MDR and the global regulatory landscape.
Practical Compliance Support
Actionable solutions tailored to your product and business needs.
Documentation Guidance
Clear, structured and audit-ready documentation support.
Market Access
Smooth and safe access to the European market.
What is EU MDR?
EU MDR (Regulation (EU) 2017/745) is the legal framework governing the safety, performance and market access of medical devices sold in the European Union. It entered into force on 25 May 2017 and became applicable on 26 May 2021, replacing the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).
As a regulation rather than a directive, it applies directly and identically across every EU member state, with no room for local interpretation. It introduced stronger clinical evidence requirements, standardised technical documentation, EU-wide device traceability through UDI and EUDAMED, and continuous post-market surveillance rather than one-time approval. It also requires every manufacturer to have a named Person Responsible for Regulatory Compliance (PRRC).For manufacturers, this makes EU MDR compliance an ongoing responsibility rather than a one-time approval.
Services
- Technical Services For Design And Development Of Medical Devices
- QMS Development and Support
- Risk Management Service
- Technical Documentation Services
- Medical Device Labelling
- Audit Readiness Plan
- Design Control Requirements for Drug-Device Combination Products
- EU Medical Device Regulation
- Medical Device Testing Service
Who Needs to Comply?
EU MDR assigns distinct obligations across the supply chain:
Manufacturers
Full regulatory responsibility for design, documentation, quality management systems and clinical evaluation.
Authorised Representatives
Required for non-EU manufacturers. They act as the EU contact point and share responsibility.
Importers
Verify CE marking and the authorised-representative appointment before market entry.
Distributors
Verify CE marking, labelling and appropriate storage conditions.
Notified Bodies
Independent bodies that assess conformity for Class IIa, Class IIb and Class III devices, along with certain Class I devices.
Who Needs to Comply?
EU MDR assigns distinct obligations across the supply chain:
Class I
Lowest risk; mostly self-declared, with limited Notified Body review for sterile devices, measuring-function devices and reusable surgical instruments.
Class IIa
Low-to-medium risk; Notified Body assessment required.
Class IIb
Medium-to-high risk; Notified Body assessment required.
Class III
Highest risk, including many implantable devices; follows the most rigorous assessment route.
Key EU MDR Requirements
Requirements scale with device class and typically include General Safety and Performance Requirements (GSPR), risk management, technical documentation, clinical evaluation, a Quality Management System, post-market surveillance, vigilance reporting, UDI and EUDAMED registration, labelling and Instructions for Use, a named PRRC, and conformity assessment leading to CE marking.
Explore EU MDR Topics in Depth
- Technical Files: what belongs in your EU MDR technical documentation under Annex I, II and III.
- Risk Management (ISO 14971): building a compliant medical device risk management file.
- Labelling: EU MDR labelling and UDI marking requirements.
- GSPR: how to build a GSPR checklist that stands up to Notified Body review.
- Instructions for Use (IFU): what your IFU must include under Annex I, Section 23.4, including eIFU rules.
- List of Applicable Standards (LOAS): identifying and maintaining the standards your device needs.
- Medical Device Testing: planning testing that provides the verification and validation evidence for your technical file.
Common EU MDR Compliance Challenges
Manufacturers most often run into:
- Classification carried over from older MDD assessments without review.
- Insufficient clinical evidence.
- Mandatory EUDAMED registration, which applies from 28 May 2026 for actor, UDI/device, certificate and market surveillance modules.
- Treating post-market surveillance as a one-time report rather than a continuous process.
- Gaps in technical documentation.
- Limited Notified Body capacity and long review queues.
- Transition deadlines for legacy MDD devices, which run to 31 December 2027 for Class III and Class IIb implantable devices and to 31 December 2028 for other classes, subject to conditions.
EU MDR Consulting Services
Our EU MDR regulatory services cover every stage of market access, from classification and technical documentation to CE marking and post-market support.
Regulatory Strategy Development
Tailored advice so your product meets EU MDR requirements and gets approved without unnecessary delays.
Documentation and Submission Support
Preparing technical documentation and filing submissions to Notified Bodies.
Compliance Gap Analysis
In-depth review of your existing processes against current EU MDR requirements.
Risk Management Support
Structured risk identification, evaluation and control, aligned with ISO 14971.
QMS Development and Support
Aligning your quality processes with MDR and ISO 13485 requirements.
CE Marking Support
Guiding you through conformity assessment, the Declaration of Conformity and CE marking.
Combination Product Support
Article 117 Notified Body Opinions and device documentation for integral drug-device products.
Testing and Performance Support
Evaluating device performance characteristics as part of your technical file.
Audit Readiness Planning
Preparing your organisation for internal and external audits.
Ongoing Support and Monitoring
Continuous guidance throughout your device's lifecycle to maintain EU MDR compliance.
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our EU MDR consulting work is led by Subhash Meena, a Medical Device and Drug-Device Combination Product expert with 15+ years of experience. He has worked across Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories, spanning cardiology, orthopaedics and endosurgery.
His experience includes combination products such as pen injectors, auto-injectors and prefilled syringes, with direct Notified Body and USFDA filing experience. For manufacturers in India and worldwide, that means an EU MDR consultant who has done the work from inside the industry.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
The EU regulation (2017/745) governing medical device safety, performance and market access, applicable since 26 May 2021.
Manufacturers, Authorised Representatives, importers and distributors all have distinct legal obligations. Notified Bodies play a mandatory assessment role for all Class IIa, IIb and III devices and for certain Class I devices.
No. Most Class I devices are self-declared by the manufacturer. Class I devices that are sterile, have a measuring function or are reusable surgical instruments need limited Notified Body involvement, and all Class IIa, IIb and III devices require Notified Body assessment.
The Annex II and III evidence file demonstrating that a device meets MDR requirements, covering design, risk, clinical and post-market data.
It depends on which part is primary. Integral products regulated as medicines, such as prefilled syringes, need evidence under Article 117 that the device part meets MDR requirements. Devices with a supporting medicinal substance are regulated as Class III devices under the MDR.
A documented assessment of clinical data confirming a device is safe and performs as intended, with the depth of evidence required scaling to the device’s risk class.
It depends on your device class, how complete your existing documentation is, and Notified Body availability. Class I devices can move faster, while Class IIa, IIb and III devices also need Notified Body review, which can add many months. An early gap assessment, the first step in our EU MDR regulatory services, gives you a realistic timeline for your device.
Looking For General Support For Your Medical Business?
Let’s discuss your upcoming project.