PSUR: The Power of One: Aligning PSURs Across EU, GB and Canada

Description: Regulatory professionals today face the challenge of preparing Periodic Safety Update Reports (PSURs) that meet diverging expectations across jurisdictions. This session brings together three complementary perspectives — consulting, notified body, and strategic industry — to provide participants with practical and actionable insights.

From the consulting side, attendees will hear how different approaches to PSUR preparation have been implemented across clients – from SMEs to larger manufacturers,, what strategies have proven successful, and where recurring challenges arise.
The notified body perspective will provide insight on the approach to reviewing PSURs under EU MDR, the new GB PMS framework, as well as the Canadian MDR, highlighting particular points of divergence between requirements. There will be a focus on ensuring clarity and compliance and where certain PSUR formats can create risks.

Adding to this, the strategic industry partner will contribute insights from active participation in Medical Device Coordination Group (MDCG), linking current developments with the long-term outlook for potential alignment while recognizing jurisdiction-specific realities.

By combining these viewpoints, the session enables participants to critically assess different PSUR models, understand the practical implications for their own documentation processes, and anticipate regulatory expectations. This will support them in building efficient, adaptable PMS strategies that strengthen compliance, minimize duplication, and add value to their professional role and career.