Regulatory Updates

ICH E2D(R1) – New Expectations for ODCS, PSPs, MRPs & Digital Platforms | QbD Group

Wed, 04 Mar 2026 09:29:45 GMT

EMA Framework Qualification of Non-Mutagenic Impurities | QbD Group

María José Villarroel, Toxicology & Quality Director — Wed, 25 Feb 2026 10:26:11 GMT

MHRA publishes new IVD Roadmap | QbD Group Regulatory Update

Wed, 17 Dec 2025 09:18:00 GMT

The roadmap sets out broad timelines and planned activities across three key themes:

Proposal for a Regulation Amending MDR and IVDR | QbD RA Update

Wed, 17 Dec 2025 09:08:14 GMT

The proposal introduces wide-ranging changes across the device lifecycle. It focuses on simplification and proportionality, including more flexible requirements for the Person Responsible for Regulatory Compliance, a move away from fixed certificate validity periods, and more risk-based, proportionate re-certification through periodic reviews. It also broadens the types of clinical and non-clinical data that may be used to demonstrate compliance and introduces the concept of well-established technologies with adapted requirements.

Draft EU Implementing Act on Notified Body Procedure | QbD RA Update

Wed, 17 Dec 2025 08:57:30 GMT

The feedback period runs from 12 December 2025 to 23 January 2026. The draft regulation aims to address inconsistent practices, improve predictability, and ensure consistent conformity assessment across the EU internal market. Once adopted, the draft is expected to make Notified Body procedures more predictable and transparent for manufacturers, with clear timelines for applications, audits, product verification, and re-certification, as well as detailed cost transparency.

MDCG on Breakthrough Devices Released | QbD Group Regulatory Update

Wed, 17 Dec 2025 08:28:58 GMT

The guidance sets out the criteria for BtX designation, requiring devices to demonstrate both a high degree of novelty relating to the technology, the associated clinical procedure, or the application of the device in clinical practice, and a reasonably expected significant positive clinical impact on patient or public health. The targeted conditions must be life-threatening, meaning likely to result in death without major medical intervention, or irreversibly debilitating, involving substantial and permanent impairment of daily functioning or quality of life.

New Update of Appendix 1 of the Nitrosamines Guideline | QbD Group

Pablo Palomar, Senior Toxicology Officer at QbD Group — Thu, 04 Dec 2025 09:39:03 GMT

What's new?

This update introduces the Acceptable Intake (AI) values for new nitrosamine drug substance–related impurities (NDSRIs) associated with the manufacturing processes of several active substances (levodropropizine, cytisine, lumefantrine, mifepristone, tapentadol, and selumetinib). In addition, the acceptable intake for the nitrosamine arising from the use of the fragrance ingredient methyl N-methylanthranilate has also been established.

EC Confirms 4 EUDAMED Modules Fully Functional

Thu, 27 Nov 2025 03:00:00 GMT

This announcement represents a key milestone in the rollout of the MDR/IVDR framework and officially starts the legal compliance timelines for these modules.

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

Mon, 17 Nov 2025 15:39:40 GMT

The first call was launched on February 6^th, 2025, and closed June 30th, 2025, but was only open to sponsors of medical device clinical investigations.

Team-NB publishes 2 new Position Papers | QbD Group Regulatory Update

Mon, 17 Nov 2025 15:23:04 GMT

On October 22^nd Team-NB published two new Position Papers. One addresses changes to companion diagnostic devices under the IVDR, Annex IX, section 5.2 that require prior approval by a notified body while the other is a template agreement related to the transfer of MDR formal application and of appropriate surveillance of legacy devices specifying the terms of the transfer of MDR application(s) with, where applicable, the transfer of the appropriate surveillance activities according to Article 120 (3e) of Regulation (EU) 2017/7451 in respect of legacy devices covered by a certificate issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC.