Medical Devices (EU MDR / UK MDR)
Precision-Driven Regulatory Solutions for Global Healthcare Access
What is EU MDR (2017/745)?
The Medical Device Regulation (EU MDR 2017/745) is a stringent regulatory framework designed to ensure the safety, clinical effectiveness, and traceability of medical devices across the European Union.
It introduces:
- Stricter clinical evidence requirements
- Enhanced post-market surveillance (PMS)
- Mandatory UDI (Unique Device Identification)
- Centralized database via EUDAMED
- Greater accountability across product lifecycle
Applicable to all device classes: Class I, IIa, IIb, and III
EU MDR 2017/745
Medical Device Regulation
Our Core Capabilities
Comprehensive expertise across all aspects of medical device regulatory compliance
Regulatory Strategy & Device Classification
Define correct classification and conformity route based on MDR rules.
Technical Documentation
Preparation of Technical File / Design Dossier per MDR structure.
Clinical Evaluation (CER)
Comprehensive clinical data analysis and report generation.
Risk Management (ISO 14971)
Structured risk analysis and hazard evaluation.
EU Authorised Representative
Legal representation for non-EU manufacturers.
UK Responsible Person
Support for UKCA marking and MHRA registration.
End-to-End Medical Device Services
Compliance Lifecycle Approach
We do not just certify - we stay with you throughout the entire product lifecycle.
Key Advantages
Bring Your Medical Device to Europe-Faster, Safer, Fully Compliant
Partner with experts who understand both regulations and real-world approvals. We navigate the complex MDR landscape so you can focus on what matters - your patients.
