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Regulatory Updates

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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New revision of Team-NB Position Paper on European AI Act

New Team-NB Position Paper Released on IVDR certification process

New Revision to MDCG 2020-16 Guidenance Document Released

Fifth revision to MDCG 2019-6 Guidance document released

Call for expression of interest in coordinated assessment of clinical investigations/performance studies

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

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

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Events calendar

Industry
Service

September

17.09 - 18.09

Pharma & Biotech

Farmaforum

Madrid, Spain

23.09 - 23.09

Pharma & Biotech

BioWin day

Namur, Belgium

25.09 - 25.09

Pharma & Biotech
Medical Devices
In Vitro Diagnostics

QbD Group x Gevers Roadshow: Liège

Liège - LégiaPark

29.09 - 01.10

Medical Devices
Pharma & Biotech

TOPRA annual Symposium

Berlin, Germany

October

07.10 - 08.10

Vigilance
Pharma & Biotech

World Drug Safety Congress

Amsterdam, The Netherlands

07.10 - 10.10

Pharma & Biotech
Medical Devices

RAPS US Convergence

Pittsburgh, UK

16.10 - 16.10

Medical Devices

Healixia Clinical Conference

Brussels, Belgium

19.10 - 20.10

In Vitro Diagnostics

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

Brussels, Belgium

23.10 - 23.10

In Vitro Diagnostics
Medical Devices
Pharma & Biotech

QbD Group x Gevers Roadshow: Liège

Diepenbeek - BioVille

23.10 - 24.10

Medical Devices

Team-PRRC Annual Summit

Rome, Italy

25.10 - 28.10

Medical Devices

TCT 2025

San Francisco (CA), USA

28.10 - 30.10

Pharma & Biotech

CPHI Frankfurt

Frankfurt, Germany

November

17.11 - 20.11

Medical Devices

Medica 2025

Düsseldorf, Germany

17.11 - 20.11

Pharma & Biotech
Medical Devices

Medica

Dusseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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Upcoming webinars

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PMS & PMCF Compliance for Medical Devices Under EU MDR

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