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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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MDCG 2022-13 Rev.1 – Designation, Re-assessment, and Notification Process for Conformity Assessment and Notified Bodies

Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence Repair (MDCG 2024-1-5)

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

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Events calendar

Industry
Service

July

27.07 - 31.07

In Vitro Diagnostics

ADLM

Chicago (IL), USA

August

29.08 - 01.09

Medical Devices

ESC Congress

Madrid, Spain

September

07.09 - 11.09

Medical Devices

LSI Europe

London, UK

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

Medical Devices

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
Medical Devices

CPHI Europe

Frankfurt, Germany

November

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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