BSI Meet the Experts IVDR 2025: Engaging with Notified Bodies to Better Support My Clients

November 2025, Amsterdam

I attended the BSI Meet the Experts: In Vitro Diagnostic Regulation, the annual in-person event organised by BSI in Amsterdam on November 11, 2025. A full day dedicated to the complexities of the IVDR, covering CE submissions, post-certification requirements, and workshops led directly by BSI’s IVDR specialists.

BSI is one of the leading European notified bodies for medical devices and in vitro diagnostics. I had the opportunity to work with them when I was employed by medical device manufacturers and I retain a very positive experience of their approach. Attending their events means returning to a perspective I know well, while confronting it with the most recent developments in IVDR implementation.

Keeping up to date with the regulatory requirements applicable to in vitro diagnostics is a professional necessity. But exchanging directly with a notified body’s evaluators goes beyond reading the texts: it means understanding what a successful submission actually involves, what the real post-certification watchpoints are, and what evaluators genuinely expect — insights that I bring directly to my clients.

References:

• BSI Meet the Experts IVDR 2025. https://page.bsigroup.com/MTEIVD25
• Regulation (EU) 2017/746 on in vitr diagnostics (IVDR). http://data.europa.eu/eli/reg/2017/746/oj
• © One Health Compliance, 2025