Manufacturers who want to place medical devices on the EU market must comply with the Medical Device Regulation (MDR) Regulation (EU) 2017/745. The regulation aims to increase the quality and traceability of medical devices.
The Regulation lays down the rules for placing on the market, making available on the market, or putting into service medical devices and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.
- Assuring the safety of medical devices in global markets.
- To ensure a consistent risk and quality management system.
- Our services to manufacturers of medical devices includes, MDR & IVDR (In vitro diagnostic medical devices) REGULATION (EU) 2017/746.