Medical Device Regulation

MDR Compliance

At Zahrawi Surgical Instruments, regulatory compliance is a core part of our commitment to quality, safety, and customer trust. 

What is MDR?

The Medical Device Regulation (MDR) is a comprehensive regulatory framework introduced by the European Union to replace the previous Medical Device Directive (MDD). It governs the safety, performance, and quality of medical devices

Our MDR Commitment

Zahrawi Surgical Instruments is fully committed to maintaining MDR compliance across our entire product range. This includes:

• Product Classification & Conformity Assessment
  Each of our instruments is classified according to MDR guidelines and undergoes the appropriate conformity assessment procedures to ensure they are safe and effective for their intended use.

• Technical Documentation
  We maintain complete and up-to-date technical files for all devices, including clinical evaluations, risk assessments, and performance data, in line with MDR Annex II and III requirements.

• UDI (Unique Device Identification)
  Our products are labeled with UDI codes for full traceability across the supply chain, in compliance with MDR labeling requirements.

• Post-Market Surveillance & Vigilance
  We have robust systems in place to monitor the performance of our devices in real-world use and respond proactively to any feedback or incidents.

Ongoing Compliance

MDR compliance is not a one-time task—it's an ongoing responsibility. We continually update our systems, documentation, and product testing procedures to meet the evolving regulatory landscape and exceed client expectations.