In 2024, significant regulatory updates were introduced affecting medical device software (MDSW) within the European Union (EU) and Medical Device Single Audit Program (MDSAP) member countries. These changes aim to enhance patient safety, streamline compliance processes, and adapt to technological advancements in the medical device sector.
European Union (EU) Regulatory Updates
On July 9, 2024, the EU enacted Regulation (EU) 2024/1860, amending the existing Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This amendment focuses on several key areas:
Gradual Roll-Out of EUDAMED: The European Database on Medical Devices (EUDAMED) is being implemented in phases to ensure a smooth transition and full functionality.
Supply Chain Transparency: Manufacturers are now required to inform authorities about any interruptions or discontinuations in the supply of medical devices, aiming to prevent shortages and ensure continuous patient care.
Extended Transitional Provisions: Certain in vitro diagnostic medical devices have been granted extended transition periods, allowing manufacturers additional time to comply with new regulatory requirements.
Additionally, the Medical Device Coordination Group (MDCG) released guidance documents in November 2024 to assist stakeholders in implementing these changes effectively.
Medical Device Single Audit Program (MDSAP) Updates
The MDSAP, which facilitates a single audit process for medical device manufacturers across multiple jurisdictions, introduced notable updates in 2024:
Audit Approach Revision: On August 6, 2024, the MDSAP Audit Approach document was updated to Version 009. This revision includes modifications to audit tasks related to device marketing authorization, facility registration, purchasing, adverse event reporting, and quality management systems.
Program Expansion: The Health Sciences Authority (HSA) of Singapore joined the MDSAP as an observer, indicating potential future expansion of the program's reach.
Global Implications
These regulatory updates reflect a global trend toward harmonizing medical device regulations, particularly concerning software as a medical device (SaMD). The EU's emphasis on supply chain transparency and extended compliance timelines provides a framework that other regions may adopt to ensure patient safety and market stability. Simultaneously, the MDSAP's evolving audit processes and expanding membership signify a move toward more unified and efficient regulatory oversight worldwide.
For medical device software manufacturers, staying abreast of these developments is crucial. Proactive engagement with regulatory changes not only ensures compliance but also enhances the potential for global market access and competitiveness.
References:
European Commission. (2024). Regulation (EU) 2024/1860 – Changes to MDR and IVDR. Retrieved from mdrregulator.com
European Commission. (2024). Medical Devices Regulation and IVDR Updates. Retrieved from health.ec.europa.eu
U.S. Food and Drug Administration. (2024). Medical Device Single Audit Program (MDSAP) Updates. Retrieved from fda.gov
Therapeutic Goods Administration. (2024). MDSAP Audit Approach Revision and Program Expansion. Retrieved from tga.gov.au
No comments:
Post a Comment