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

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

Select your

or

Select your

Industry

or

Service

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

Recent Posts

New MDCG Guidance Documents Released: Key Updates and Insights

New MDCG & Stakeholders Survey on MDR/IVDR Certifications and Applications Released by Notified Bodies

EU Parliament Passes Groundbreaking Proposal

New MDCG Guidance on Safety Reporting for Performance Studies of In Vitro Diagnostic Medical Devices under EU Regulation 2017/746 Released

New MDCG Guidance on Investigator’s Brochure Content for Clinical Investigations of Medical Devices

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

data-not-found No Items Found! Please Try Some Different Keywords
circle news

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
Load More
circle-box circle-box-mob

Upcoming webinars

webinar-image

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
Read more