The April Issue of EU MDR & IVDR Insider Is Here
Providing expert insights and practical resources for medical device and IVD manufacturers.
This issue covers essential guidance on post-market surveillance (PMS), vigilance reporting, and the implications of updated UK regulations.
What’s Inside This Edition:
Update: Welcome to the April Issue
By Bassil Akra, PhD
Dr. Akra highlights key developments, including insights from the recent European Commission evaluation of MDR and IVDR and upcoming events such as the QMS Accelerator Program in Munich.
5 Key Perspectives: Post-Market Surveillance
We gathered articles from subject matter experts to deliver insights into post-market surveillance, vigilance, reporting, and risk in the EU and UK:
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CĂ©cile van der Heijden (Axon Lawyers) discusses manufacturers' continuing obligations even after a medical device or IVD is discontinued, including vigilance reporting, post-market surveillance, and data retention requirements.
- Yu Jin (SGS Belgium) outlines seven common PMS and PMCF mistakes under EU MDR, highlighting gaps in integration, planning, and documentation—and how to fix them.
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Vaida Jukneviciute (MedTech Europe) outlines challenges in vigilance reporting, advocating for optimized processes and clearer responsibilities between competent authorities and Notified Bodies.
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Azam Khorshidi (DEKRA Certification) addresses persistent gaps in PMS compliance and stresses the importance of proactive and risk-based approaches to effectively manage product safety and regulatory obligations.
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Stephen Lee (ABHI) shares insights on how updated UK PMS regulations align and differ from the EU, emphasizing strategic implications for global compliance and providing practical steps manufacturers should follow.
Webinar Recording
Best Practices and Challenges in Post-Market Surveillance
Did you miss the webinar featuring Muna Kebede, Julia Hoyer, Marta Carnielli, and Milad Masjedi?
Access the full recording, transcript, and slides for expert insights on continuous data collection, precise documentation, and tailored PMS strategies.
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