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
Good Manufacturing Practice (cGMP)
Establish and implement an effective tailored cGMP system in line with requirements.
+ Learn MorePost-Market Surveillance and Vigilance
Establishment and implementation of PMS to review experience gained from devices in the post-production phase.
+ Learn MoreApplication of Risk Management to Medical Devices
Integration of a risk management system into your existing quality management system.
+ Learn More