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

Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864

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.

Clinical

Regulatory Updates

Regulatory Updates

Select your

or

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

Recent Posts

New MDCG Guidance documents released

Expert Panel Advice on SARS-CoV-2

New revision to EMA Guidance documents released

New revisions of the Preliminary Assessment Review templates, forms and annexes

Second revision to MDCG 2023-3 Guidance document released

New MDCG 2020-16 Revision 3 Guidance Documents Released

MDCG 2022-3 Rev.1 released

Revision of MDCG 2019-13 released

New MDCG 2024-16 form released

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

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