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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Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2

MDCG 2024-10: Clinical Evaluation Guidelines for Orphan Medical Devices

New MDCG Guidance Documents Released: Key Updates and Insights

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

Latest Update on Appendix 1 of the Nitrosamine Guidelines

EU Parliament Passes Groundbreaking Proposal

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

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

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Events calendar

Industry
Service

November

17.11 - 20.11

Medical Devices

Medica 2025

Düsseldorf, Germany

December

11.12 - 11.12

Medical Devices
Pharma & Biotech

Dutch Life Science conference

Leiden, The Netherlands
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