The MDR, or Medical Device Regulation 2017/745 is the latest set of regulations that govern medical devices in Europe.
Compliance with this Regulation is mandatory for medical device companies around the world that want to sell their products on the European market. The Medical Devices Regulation (EU) 2017/745 entered into force in May 2017 and has officially replaced the Medical Device Directive (MDD 83/42 EEC). The extent to which these changes will affect your company depends on the type of device manufactured and the role you hold in industry. In most cases, whether you are a manufacturer, distributor or importer, significant changes must be made to the Quality Management System, and the technical documentation.
Details of services offered:
- Comprehensive Gap Assessment & Compliance Roadmap
- General Safety & Performance Requirements (GSPR) Compliance
- Technical Documentation Development
- Clinical Evaluation & Performance Evaluation
- PMS, PSUR & Vigilance Systems (Annex III)
- UDI, Labelling & EUDAMED Compliance
- QMS Upgrades to MDR & IVDR Requirements
- Economic Operator Compliance
- Notified Body Support & Audit Preparation
- Legacy Device & Legacy IVD Transition Support
- Training & Competency Development
- Strategic Regulatory Intelligence (EU-Focused)
PNS MED HEALTH 