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

Recent Posts

Update manual on borderline classification IVDR and MDR published

Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR

Adoption of Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application and new revision of MDCG 2024-14

New MDCG position paper released on the timelines of implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

Adoption of Decision 2025/1324 on expert panels in the field of medical devices

4 key guidance documents released under the EU MDR and IVDR frameworks

Launch of the first phase of the COMBINE Project 1 pilot - "all-in-one” coordinated assessment

New Manufacturer Incident Report template and IMDRF terminologies for categorized Adverse Event Reporting released

New revision of Team-NB Best Practice Guidance released

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

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Events calendar

Industry
Service

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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Scaling Pharmacovigilance in Europe: A Practical Guide for Pharma SMEs and Biotechs

This live webinar will provide clear, experience-based guidance on how to manage pharmacovigilance (PV) across Europe without overextending your resources. You’ll learn how to balance global consistency with country-specific requirements, meet strict European timelines with lean teams, and apply practical, proven strategies that strengthen both central oversight and local execution.
Vigilance
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