EDB Hosts Webinar with TÜV Rheinland on MDR Compliance and Local Lab Development
Surgical instrument exports from Pakistan to the EU face new challenges due to the Medical Devices Regulation (MDR) that mandates compliance with strict standards by 2027. Previously adhering to the Medical Device Directive (MDD), Pakistani exporters now confront significant barriers, including the presence of a single certifying body, high costs, and delays in Certification , threatening a potential 97% loss in EU exports.
To address these challenges and capitalize on a global market valued at USD 637 billion, Pakistan must enhance regulatory frameworks, develop local testing facilities, and secure additional certifying bodies. In support of these efforts, the Engineering Development Board (EDB) organized a webinar with TÜV Rheinland, focusing on MDR compliance and the establishment of local labs, which could reduce foreign reserves outflow. Over 40 industry stakeholders participated, appreciating the initiative and urging further support, including a seminar in Sialkot to discuss infrastructure and auditor training. The industry also seeks to engage another accredited agency for certification at a competitive cost, underscoring the need for expanded options to sustain and grow Pakistan’s surgical instrument exports.