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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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New Update of Appendix 1 of the Nitrosamines Guideline - QbD Group
4 Dec 2025

New Update of Appendix 1 of the Nitrosamines Guideline - EMA/42261/2025/Rev. 11

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Regulatory Update - EC Confirms 4 EUDAMED Modules Fully Functional - QbD Group
27 Nov 2025

EC Confirms 4 EUDAMED Modules Fully Functional

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Second call for expression of interest in coordinated assessment of clinical investigations / performance studies
17 Nov 2025

Second call for expression of interest in coordinated assessment of clinical investigations / performance studies

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Team-NB publishes two new Position Papers - QbD Group RA update
17 Nov 2025

Team-NB publishes two new Position Papers

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New manual on borderline classification IVDR and MDR - QbD Group
30 Sep 2025

Update manual on borderline classification IVDR and MDR published

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Revised Team NB Position Paper on Best Practices for Submission of Technical Documentation under IVDR
30 Sep 2025

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

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Adoption of Commission Delegated Regulation (EU) 2025/788 - QbD Group
30 Sep 2025

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

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New MDCG position paper released on the timelines of implementation of Master UDI-DI - QbD Group
30 Sep 2025

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

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Adoption of Decision 2025/1324 on expert panels in the field of medical devices - QbD Group
30 Sep 2025

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

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EU New Variations Guidelines to Streamline Lifecycle Management of Medicines - QbD Group
30 Sep 2025

EU New Variations Guidelines to Streamline Lifecycle Management of Medicines

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EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466 | QbD Group
11 Sep 2025

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466

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RA Update - ICH Draft Q3E Guideline Now Open for Consultation - QbD Group
13 Aug 2025

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

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Expanded eIFU Eligibility under EU Regulation 2025/1234
3 Jul 2025

Expanded eIFU Eligibility under EU Regulation 2025/1234

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FDA Deadline Update - Risk of nitrosamine drug substance-related impurity
1 Jul 2025

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

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4 key guidance documents released under the EU MDR and IVDR frameworks - Regulatory Update
23 Jun 2025

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

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Launch of the first phase of the COMBINE Project 1 pilot - Regulatory Update
23 Jun 2025

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

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RA update - Nitrosamines Update EMA/409815/2020 Rev.22 - QbD Group
2 Jun 2025

Nitrosamines Update EMA/409815/2020 Rev.22

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RA update - New Manufacturer Incident Report template and IMDR terminologies for categorized Adverse Event Reporting released - QbD Group
14 May 2025

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

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RA Update - New UK Clinical Trials Regulations: Key Updates and What They Mean
5 May 2025

New UK Clinical Trials Regulations: Key Updates and What They Mean

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RA Update - New revision of Team-NB Best Practice Guidance released
23 Apr 2025

New revision of Team-NB Best Practice Guidance released

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RA update - New revision of Team-NB Position Paper on European AI Act
23 Apr 2025

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

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RA update - New Team-NB Position Paper released
23 Apr 2025

New Team-NB Position Paper Released on IVDR certification process

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RA update - New Revision to MDCG 2020-16 Guidenance Document Released
23 Apr 2025

New Revision to MDCG 2020-16 Guidenance Document Released

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RA Update - The fifth revision to MDCG 2019-6 splits two questions into sub questions, updates the answers to five existing questions and introduces a new Q&A - QbD Group
5 Mar 2025

Fifth revision to MDCG 2019-6 Guidance document released

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RA Update - Call for expression of interest in coordinated assessment of clinical investigations/performance studies - QbD Group
5 Mar 2025

Call for expression of interest in coordinated assessment of clinical investigations/performance studies

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RA update - PMS Statutory Instrument + MHRA Guidance released - QbD Group
6 Feb 2025

PMS Statutory Instrument + MHRA Guidance released (Great Britain)

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RA update - New MDCG Guidance documents released - QbD Group
6 Feb 2025

New MDCG Guidance documents released

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RA update - Expert Panel Advice on SARS-CoV-2 - QbD Group
6 Feb 2025

Expert Panel Advice on SARS-CoV-2

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Regulatory update - New revision to EMA Guidance documents released - QbD Group
27 Jan 2025

New revision to EMA Guidance documents released

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Regulatory update - New updates to MDCG Guidance document released - QbD Group
27 Jan 2025

New revisions of the Preliminary Assessment Review templates, forms and annexes

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Regulatory update - Second revision to MDCG 2023-3 Guidance document released - QbD Group
27 Jan 2025

Second revision to MDCG 2023-3 Guidance document released

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10 Jan 2025

New MDCG 2020-16 Revision 3 Guidance Documents Released

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24 Dec 2024

MDCG 2022-3 Rev.1 released

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23 Dec 2024

Revision of MDCG 2019-13 released

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12 Dec 2024

New MDCG 2024-16 form released

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9 Dec 2024

New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

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9 Dec 2024

New MDCG Guidance document released

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26 Nov 2024

New Q&A released on the gradual roll-out of EUDAMED

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25 Nov 2024

EMA launched a new draft guideline on risk management requirements for elemental impurities in veterinary medicinal products

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15 Nov 2024

MDCG 2023-3 Rev 1 released

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6 Nov 2024

MDCG 2024-13 and MDCG 2022-5 Rev 1 released

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5 Nov 2024

New Q&A on the obligation to inform in case of interruption or discontinuation of supply

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29 Oct 2024

First Revision of MDCG 2021-25 Released

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14 Oct 2024

MDCG 2024-12 released

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14 Oct 2024

MDCG 2024-11 released

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14 Oct 2024

Newly Listed Harmonized Standards

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1 Oct 2024

Revised MDCG 2021-4 Guidance Documents Released

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18 Sep 2024

The FDA releases revision of guidance regarding Control of Nitrosamine Impurities in Human Drugs

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12 Jul 2024

New MDCG Guidance Documents Released

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11 Jul 2024

Publication of Amendments to Regulation (EU) 2024/1860

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9 Jul 2024

MDCG: First Revision on the Guidance on Standardisation for Medical Devices

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Regulatory update - New Update of Appendix 1 of the Nitrosamines Guideline - QbD Group
9 Jul 2024

New Update of Appendix 1 of the Nitrosamines Guideline

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MDCG 2022-13 Rev.1 - QbD Group
27 Jun 2024

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

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

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

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Updated Guidance on MDR Surveillance: MDCG 2022-4, Revision 2 - QbD Group
27 Jun 2024

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

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Clinical Evaluation Guidelines for Orphan Medical Devices - QbD Group
27 Jun 2024

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

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27 May 2024

New MDCG Guidance Documents Released: Key Updates and Insights

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27 May 2024

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

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14 May 2024

Latest Update on Appendix 1 of the Nitrosamine Guidelines

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30 Apr 2024

EU Parliament Passes Groundbreaking Proposal

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23 Apr 2024

New EMA Guideline on Environmental Risk Assessment for Human Medicinal Products

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22 Apr 2024

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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22 Apr 2024

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

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15 Mar 2024

New MDCG Guidance Released: Detailed Instructions for Clinical Investigation Plans in Medical Device Studies

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15 Mar 2024

New MDCG Guidance on Updating the European Medical Device Nomenclature (EMDN)

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15 Mar 2024

New MDCG Guidance Released: Device-Specific Vigilance Document

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Blog - Newly Published Harmonized Standards for MDR and IVDR Compliance - QbD Group
14 Mar 2024

Newly Published Harmonized Standards for MDR and IVDR Compliance

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23 Feb 2024

EU Council Endorses Proposal to Amend IVDR and MDR Regulations

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23 Feb 2024

Proposed Amendments to IVDR and MDR: Transitional Provisions, EUDAMED Roll-Out, and Supply Chain Interruptions

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23 Jan 2024

Comprehensive Overview of Language Requirements under IVDR/MDR for Medical Device Manufacturers

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New EMA FAQ on medicinal products development and assessment involving a CDx
23 Jan 2024

New EMA FAQ on medicinal products development and assessment involving a CDx

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