EU MDR Compliance & CE Marking Consulting for Medical Devices
Navigate the complexities of EU MDR 2017/745 with confidence. NexorTest Technologies provides end-to-end CE marking consulting -- from device classification and GSPR compliance to Notified Body submissions and EU market entry.
EU MDR Device Classification Pathways
EU MDR 2017/745 classifies medical devices into four risk-based classes, each with distinct conformity assessment requirements.
Class I
General laboratory instruments, specimen receptacles, buffer solutions, and wash solutions. Self-assessment permitted for non-sterile, non-measuring devices.
Class IIa
Default classification for IVDs not covered by other rules. Includes clinical chemistry analyzers, pregnancy self-tests, and antimicrobial susceptibility tests.
Class IIb
Blood typing (non-ABO/Rh), companion diagnostics, genetic testing, HLA typing, tumor markers, and prenatal screening for congenital conditions.
Class III
Blood screening for HIV, Hepatitis B/C, HTLV; blood grouping (ABO, Rh, Kell); transfusion-transmissible agents. Requires EU Reference Laboratory involvement.
Comprehensive EU MDR CE Marking Services
End-to-end regulatory consulting covering every aspect of EU MDR compliance and CE marking certification.
EU MDR Compliance Strategy
Develop a tailored regulatory roadmap for your device. We analyze your classification, identify applicable GSPRs, and create a clear pathway to CE marking under EU MDR 2017/745.
CE Marking Certification
Complete CE marking support from initial classification through to Declaration of Conformity. We ensure your device meets all regulatory requirements for EU market access.
Notified Body Submission Support
Strategic Notified Body selection, application preparation, and submission management. We liaise with designated Notified Bodies to streamline your conformity assessment.
Technical Documentation (Annex II/III)
Comprehensive technical file preparation per EU MDR Annex II and III requirements, including device description, design verification, GSPR checklist, and manufacturing information.
Clinical Evaluation Reports (CER)
Robust clinical evaluation per MEDDEV 2.7/1 Rev 4 and EU MDR Article 61. We develop clinical evaluation plans, conduct literature reviews, and prepare CERs that satisfy Notified Bodies.
EU Authorized Representative
For non-EU manufacturers, we provide EU Authorized Representative services per Article 11, including EUDAMED registration, competent authority liaison, and vigilance reporting.
Post-Market Surveillance (PMS/PSUR)
Design and implement PMS systems, periodic safety update reports (PSURs), and vigilance procedures compliant with EU MDR Articles 83-92 and post-market requirements.
Risk Management (ISO 14971)
Full risk management lifecycle per ISO 14971:2019, including hazard identification, risk analysis, risk evaluation and control, residual risk assessment, and production/post-production monitoring.
SaMD EU MDR Article 22
Specialized regulatory strategy for Software as a Medical Device under EU MDR, including classification per Rule 11, cybersecurity requirements, and software lifecycle documentation (IEC 62304).
Your Trusted EU MDR Consulting Partner
With deep expertise in EU MDR 2017/745, NexorTest Technologies has guided hundreds of manufacturers through the CE marking process -- from startups launching their first device to enterprises transitioning from MDD.
Deep Notified Body Relationships
Established working relationships with 15+ EU Notified Bodies for faster, smoother submissions.
MDR Transition Specialists
Proven track record transitioning MDD-certified devices to full EU MDR compliance before regulatory deadlines.
All Device Classes Covered
From Class I self-certification to Class III and AIMD -- we handle the full spectrum of medical device complexity.
Dedicated EU Regulatory Team
In-house regulatory affairs professionals with decades of combined EU MDR and MDD experience.
Integrated Testing & Consulting
ISO/IEC 17025 accredited labs combined with regulatory expertise for a seamless compliance journey.
Your Pathway to CE Marking
A proven 6-step methodology that takes your medical device from regulatory strategy through to EU market entry.
Device Classification & GSPR Gap Analysis
We classify your device per EU MDR rules (Annex VIII), identify applicable GSPRs, and perform a detailed gap analysis against current documentation and evidence.
Technical Documentation Preparation
Develop comprehensive technical files per Annex II and III, including device description, design and manufacturing information, risk analysis, and GSPR compliance evidence.
Clinical Evaluation & Evidence Strategy
Conduct or update your clinical evaluation per Article 61, develop clinical evaluation plans, perform systematic literature reviews, and prepare robust CERs.
Notified Body Selection & Submission
Strategically select the optimal Notified Body based on scope, capacity, and timelines. Prepare and manage the complete conformity assessment submission.
CE Marking Certification
Navigate Notified Body audits, respond to queries, address findings, and secure your CE certificate and EU Declaration of Conformity for lawful market placement.
EU Market Entry & PMS Setup
Complete EUDAMED registration, UDI assignment, establish post-market surveillance systems, and set up ongoing compliance monitoring for sustained market access.
Medical Device Sectors We Support
NexorTest Technologies delivers EU MDR consulting across a wide range of medical device sectors and technologies.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
Frequently Asked Questions About EU MDR
Get answers to common questions about EU MDR compliance and CE marking for medical devices.
What is EU MDR?
EU MDR (Medical Device Regulation 2017/745) is the European Union’s comprehensive regulatory framework that replaced the Medical Devices Directive (MDD 93/42/EEC). It establishes stricter requirements for safety, performance, clinical evidence, and post-market surveillance of medical devices sold in the EU market. The regulation introduces enhanced scrutiny for higher-risk devices and requires all manufacturers to demonstrate compliance with General Safety and Performance Requirements (GSPRs). Class III custom devices must comply by May 2026.
How to select a Notified Body?
Selecting a Notified Body involves evaluating their designation scope to ensure they cover your device type and classification, assessing their current capacity and review timelines, understanding their audit approach and documentation requirements, checking their NANDO database listing, and considering geographic proximity and language capabilities. Due to limited Notified Body capacity under EU MDR, early engagement and application is critical. NexorTest maintains relationships with 15+ Notified Bodies and can recommend the best fit for your device.
How long does CE marking take?
CE marking timelines vary by device class: Class I devices (self-certified) typically take 3-6 months. Class IIa devices require 8-14 months including Notified Body review. Class IIb devices generally need 12-18 months. Class III devices can take 18-24+ months due to extensive scrutiny. Timelines depend on documentation readiness, clinical evidence availability, Notified Body capacity, and whether you are transitioning from MDD or submitting a new application. NexorTest’s streamlined process helps reduce these timelines.
What are GSPRs?
GSPRs (General Safety and Performance Requirements) are defined in Annex I of EU MDR 2017/745. They comprise 23 requirements covering general requirements for safety and performance, requirements regarding design and manufacture, information supplied with the device (labeling), and specific requirements for certain device categories. Manufacturers must demonstrate compliance with all applicable GSPRs through a systematic checklist cross-referencing standards, test reports, clinical data, and risk management documentation.
What are CE marking requirements under EU MDR?
CE marking under EU MDR requires manufacturers to correctly classify their device (Class I, IIa, IIb, or III), prepare comprehensive technical documentation per Annex II and III, demonstrate compliance with all applicable GSPRs, conduct a clinical evaluation, implement a quality management system (ISO 13485), and establish post-market surveillance procedures. For higher-risk devices (Class IIa, IIb, III), certification from a designated Notified Body is mandatory. An EU Authorized Representative is required for non-EU manufacturers.
What is technical documentation under EU MDR?
Technical documentation under EU MDR, as defined in Annexes II and III, includes a comprehensive device description and specifications, information on design and manufacturing, GSPR compliance checklist with supporting evidence, risk management documentation per ISO 14971, clinical evaluation report (CER), biocompatibility and performance testing data, labeling and instructions for use, and a post-market surveillance plan. This documentation must be continuously updated throughout the device lifecycle.
What is an EU Authorized Representative?
An EU Authorized Representative (EU AR) is a legal or natural person established within the European Union who acts on behalf of a non-EU manufacturer. Under EU MDR Article 11, manufacturers outside the EU must designate an EU AR before placing devices on the market. The EU AR’s responsibilities include maintaining registration in EUDAMED, facilitating communication with competent authorities, verifying that technical documentation and EU declarations of conformity are available, and cooperating with authorities on vigilance and corrective actions.
Can NexorTest help with MDR transition?
Yes, NexorTest Technologies provides comprehensive MDR transition support for manufacturers moving from MDD/AIMDD to EU MDR. Our services include gap analysis between current MDD documentation and MDR requirements, GSPR compliance mapping, clinical evaluation updates, technical documentation remediation, Notified Body re-engagement strategy, EUDAMED registration support, UDI implementation, and post-market surveillance system upgrades. Class III and custom devices must complete transition by May 2026.
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