Medical Device Software (MDSW) including Software as a Medical Device (SaMD) is rapidly transforming healthcare delivery. The regulatory framework for SaMD in the EU is primarily governed by the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
Medical Device Software Regulation in the European Union – Full Article
This white paper, written by Michael Ageboh, PhD, RAC, addresses the following:
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- Software qualification and classification
- Conformity assessment
- Involvement of Notified Bodies
- Safety and performance requirements
- Clinical and performance evaluations
- Vigilance and post-market surveillance
- Requirement for Unique Device Identifier (UDI)
- Specific challenges and considerations for MDSW
- Notable compliance timelines in the EU
- The future of SaMD regulation in the EU
- Opportunities for innovation and patient safety
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To download the full article and delve deeper into the regulatory landscape surrounding Medical Device Software (MDSW) and Software as a Medical Device (SaMD) in the European Union (EU), please click here.
The future of medical device software regulation in the EU
The future of SaMD regulation in the EU holds promising opportunities for innovation, patient safety, and improved healthcare outcomes, provided that stakeholders proactively address the evolving challenges and collaborate to develop robust and adaptable regulatory frameworks. MedEnvoy offers assistance to manufacturers in navigating these challenges within the digital health space.
If you have any questions regarding medical device software regulation or require relevant training/consulting services, get in touch.
Learn more about the regulatory landscape of medical device software
How the New MDR/IVDR Applies to Selling Software as a Medical Device (SaMD)
How the EU Importer Process Works