In a development for medical device regulation, the Global Medical Device Nomenclature (GMDN) has joined forces with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to strengthen the functionality of the MHRA's Public Access Registration Database (PARD).
The integration of GMDN within PARD aims to improve patient safety, streamline the classification, promote transparency, and enhance accessibility to vital medical device information.
The GMDN is recognised as an international standard for identifying and classifying medical devices and will play a pivotal role in supporting the MHRA's efforts to create a robust and efficient regulatory framework. By incorporating GMDN Codes into PARD, the MHRA ensures a common language and coding system that fosters seamless communication between regulatory bodies, manufacturers, healthcare professionals, and patients.
The integration of GMDN within PARD strengthens the MHRA's post-market surveillance capabilities. By utilising GMDN Codes, the agency can efficiently track and analyse adverse events, product recalls, and safety concerns. The standardised coding system enables rapid identification of specific device types, allowing the MHRA to take timely regulatory actions to ensure patient safety and maintain the integrity of the market.
Dr Laura Squire, MHRA chief healthcare quality & access officer, said: “Our work with GMDN Agency to strengthen PARD will give us better data about medical devices on the market and enable us to improve our understanding of their relative safety and performance. More consistent data across MHRA systems and the wider health and social care system will be to the benefit of patients and users of medical devices.”
Another of the key benefits of incorporating GMDN Codes into PARD is the standardised classification of 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 standardisation significantly reduces errors, simplifies the registration process, and saves valuable time for all stakeholders involved.
Deniz Bruce, CEO of the GMDN Agency, said, "We are delighted to collaborate 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."
Moreover, this collaboration fosters harmonisation with international standards as GMDN Codes are widely accepted and used by more than 70 regulatory authorities worldwide. By aligning with GMDN, the MHRA promotes seamless international trade of medical devices, reduces barriers to market access, and encourages collaboration among regulatory bodies on a global scale.
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 medical device type descriptions, manufacturer details, and GMDN Codes, empowering healthcare professionals, patients, and other stakeholders to make informed decisions about medical devices.