IVD Newsletter
Dear reader,
Once again, life as a quality/regulatory professional is never boring. New “things†pop up continuously and this month is no exception.?
Our newsletter serves as a reminder of some important IVDR-related dates and obligations. While they may not be new, they should not be overlooked. Don’t be misled into thinking, “No one will check.†Remember, any ISO 13485 auditor must verify that you comply with all applicable regulatory requirements.
In addition to a cluster of updates on MDCG documents and the first official signs that SARS-CoV-2 no longer poses?a life-threatening risk—potentially leading, finally, to a down-classification—be sure to keep an eye on the upcoming conferences where our top regulatory IVD consultants will be speaking.
Happy reading!
Maurizio Suppo | Vice President IVD - Regulatory Affairs
TOP DOWNLOAD
IVDR deadlines are looming: are you ready?
Did you know the first major IVDR transition deadline is fast approaching? By May 26, 2025, IVD manufacturers must have an IVDR-compliant QMS. Still unsure about the impact of the IVDR transition extension announced last year?
Get the answers in our whitepaper. ??
THE LATEST REGULATORY NEWS
领英推è
SEE YOU AT THESE EVENTS?
February 24-25 ?? | Brussels, Belgium ??
Our colleague Kirsten Van Garsse will share insights on the challenges of navigating performance study applications/notifications in Europe—and their impact on pharma clinical trials.
Attending the event? Don’t miss this session!
March 11 ?? | Baltimore, USA ??
Pieter Bogaert and Sara Van Wouwe will be speaking at this RAPS conference in March—they’d love to chat with you!
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