The QbD Group regulatory updates blog provides professionals in the life sciences with timely and insightful information on the latest regulatory trends, guidelines, and compliance requirements. Covering topics from pharmaceutical manufacturing standards to medical device approvals, the blog aims to support readers in navigating complex regulatory landscapes, ensuring product safety, and accelerating time to market. Whether you're involved in quality assurance, regulatory affairs, or product development, this blog offers valuable resources to keep you informed and compliant.

Regulatory Updates

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Upcoming webinars

PMS & PMCF Compliance for Medical Devices Under EU MDR

Join our expert-led webinar series on September 9 and 23 and discover how to turn PMS & PMCF compliance into clinical and strategic advantage — with exclusive insights from a notified body.

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Regulatory Updates

Regulatory Updates

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Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD

Recent Posts

New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies

New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)

New MDCG Guidance Released: Device-Specific Vigilance Document

Newly Published Harmonized Standards for MDR and IVDR Compliance

EU Council Endorses Proposal to Amend IVDR and MDR Regulations

Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions

Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers

New EMA FAQ on medicinal products development and assessment involving a CDx

Events calendar

September

07.09 - 11.09

LSI Europe

17.09 - 18.09

Farmaforum

23.09 - 23.09

BioWin day

25.09 - 25.09

QbD Group x Gevers Roadshow: Liège

29.09 - 01.10

TOPRA annual Symposium

October

07.10 - 08.10

World Drug Safety Congress

07.10 - 10.10

RAPS US Convergence

16.10 - 16.10

Healixia Clinical Conference

19.10 - 20.10

Annual EU In Vitro Diagnostics Clinical & Regulatory Conference (Q1)

23.10 - 23.10

QbD Group x Gevers Roadshow: Liège

23.10 - 24.10

Team-PRRC Annual Summit

25.10 - 28.10

TCT 2025

28.10 - 30.10

CPHI Frankfurt

November

17.11 - 20.11

Medica

December

11.12 - 11.12

Dutch Life Science conference

Upcoming webinars

PMS & PMCF Compliance for Medical Devices Under EU MDR