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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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

EU New Variations Guidelines to Streamline Lifecycle Management of Medicines

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466

ICH Draft Q3E Guideline on Extractables & Leachables Now Open for Consultation

Expanded eIFU Eligibility under EU Regulation 2025/1234

FDA Deadline Update - Risk of nitrosamine drug substance-related impurity (NDSRI)

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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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