ISLAMABAD: The Engineering Development Board (EDB) has arranged webinar collaborating Surgical Instruments & Medical Devices Industry (MDR) compliance for further strengthening the engineering industry.
According to Hira Munawar Saleemi of EDB, surgical instruments exports into the EU have been facing a new challenge in the form of requirements for compliance with Medical Devices Regulation (MDR) since beginning of 2024. All instruments entering the EU will have to be compliant with new European Regulations on the basis of biocompatibility, market surveillance, safety and efficiency of Medical Devices.
The new regulations are expected to hinder exports of Surgical Instruments and Medical Devices by 2027 in Pakistan to the EU with the new MDR (Medical Devices Regulation) imposed by EU for exports of Surgical Instruments and Medical Devices. Pakistani exporters of Surgical Instruments were previously compliant to Medical Device Directive (MDD); MDR will be imposed by 2027.
Currently, there is just one Certifying Body that has its sole monopoly being operating in Pakistan. There have been long queues and extravagant cost being involved; the company alone cannot cater to huge demand of certifying Surgical Instruments being manufactured by companies in Pakistan. Hence, Pakistan has a dire need for having additional notifying bodies for EU-MDR compliance for Surgical Industry, as non-compliance to MDR shall mean 97% loss of Surgical Instrument exports to European countries from Pakistan.
The global deadline for Medical Device Regulation (MDR) compliances is fast approaching, urging manufacturers worldwide to meet stringent new standards to ensure the safety, quality, and transparency of medical devices. For Pakistan, achieving MDR compliance is essential for expanding its footprint in the global medical device market.—PR
Copyright Business Recorder, 2024
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