GMDN and MHRA
GMDN - MHRA integration
AF Pharma, operating as your UK Regulatory Partner (UKRP), is pleased to offer our assistance in obtaining Global Medical Device Nomenclature (GMDN) codes. We recognize the significance of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in incorporating GMDN into their Public Access Registration Database (PARD) to enhance medical device regulation.
This collaboration between the GMDN and MHRA represents a significant advancement in the field of medical device regulation. By integrating GMDN into PARD, we aim to improve patient safety, simplify classification processes, promote transparency, and enhance access to critical medical device information.
GMDN is widely acknowledged as an international standard for identifying and categorizing medical devices. Its inclusion in PARD will play a vital role in supporting the MHRA's efforts to establish a robust and efficient regulatory framework. The incorporation of GMDN codes ensures a common language and coding system, facilitating seamless communication between regulatory bodies, manufacturers, healthcare professionals, and patients.
The integration of GMDN within PARD strengthens the MHRA's capabilities in post-market surveillance. Through the utilization of GMDN codes, the agency can effectively monitor and analyze adverse events, product recalls, and safety concerns. This standardized coding system enables swift identification of specific device types, enabling timely regulatory actions to uphold patient safety and market integrity.
Deniz Bruce, CEO of the GMDN Agency, expressed his satisfaction with the collaboration, stating, "We are delighted to partner with the MHRA in their pursuit of enhancing medical device regulation. The integration of GMDN within PARD will streamline processes and facilitate effective communication, ultimately promoting patient safety."
Furthermore, incorporating GMDN codes into PARD provides the benefit of standardized classification for medical devices. Manufacturers registering their devices in PARD can easily select the appropriate GMDN code that accurately represents the device's intended use and attributes. This standardization significantly reduces errors, simplifies the registration process, and saves valuable time for all stakeholders involved.
Dr. Laura Squire, MHRA Chief Healthcare Quality & Access Officer, highlighted the impact of the collaboration: "Our work with the GMDN Agency to strengthen PARD will provide us with better data about medical devices on the market and enhance our understanding of their safety and performance. Consistent data across MHRA systems and the wider healthcare system will benefit patients and users of medical devices."
Additionally, this collaboration promotes harmonization with international standards, as GMDN codes are widely accepted and used by more than 70 regulatory authorities worldwide. By aligning with GMDN, the MHRA facilitates smooth international trade of medical devices, reduces barriers to market access, and encourages global collaboration among regulatory bodies.
The integration of GMDN within PARD underscores the MHRA's commitment to transparency and accountability in the medical device industry. Accessible medical device information within PARD includes detailed descriptions of medical device types, manufacturer details, and GMDN codes. This empowers healthcare professionals, patients, and other stakeholders to make informed decisions about medical devices.
AF Pharma will support you in the process to obtain a GMDN code!