EU Medical Device Regulation (MDR) | MDV-Solve
About MDR Compliance
The Medical Device Regulation (EU) 2017/745 (MDR) establishes a modern, robust and transparent regulatory framework for medical devices. It ensures a high level of health and safety while supporting innovation.
Our MDR compliance services include:
- Gap analysis between MDD and MDR requirements
- Technical documentation preparation and review
- Classification guidance under MDR Annex VIII
- Clinical evaluation and PMCF planning
- Unique Device Identification (UDI) implementation
- EUDAMED registration support
Related Services
Application of Risk Management to Medical Devices
Integration of a risk management system into your existing quality management system.
+ Learn MoreClinical Evidence — IVDR
Under IVDR Article 56 - clinical data and performance evaluation results for device safety assessment.
+ Learn MoreDesign Control Under EN ISO 13485 & 21 CFR PART 820
Establish and implement a system for design controls for various classes of medical devices.
+ Learn More