This regulatory update summarises the Team-NB Position Paper adopted on 12 December 2025, which describes how IVD Notified Bodies will handle conformity assessments following the down-classification of SARS-CoV-2 in vitro diagnostic devices under Regulation (EU) 2017/746 (IVDR). The document reflects the IVD Expert Panel scientific advice published in January 2025 and the subsequent update of MDCG 2020-16 Revision 4, detailing classification changes, certification scenarios, and manufacturer obligations related to SARS-CoV-2 tests.

Brazil’s health authority ANVISA has released the revised 2025 edition of its Manual for the Registration of Health Products, incorporating key regulatory updates for medical device manufacturers. The manual reflects the latest changes under RDC No. 751/2022, RDC No. 848/2024, and RDC No. 556/2021, offering clear guidance on classification, technical dossiers, and grouping rules. This update is essential for any manufacturer placing medical devices on the Brazilian market.

New MDCG guidance on post-market surveillance provides clearer operational expectations for manufacturers under MDR and IVDR. PMS plans must now be more proactive, structured, and integrated into the QMS.

The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.

The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.

The FDA has finalized its 2025 guidance for sponsors on safety reporting in IND and BA/BE studies. Learn what manufacturers must update and how it affects your trials.

Discover how MDCG 2025-9 opens a new regulatory pathway for breakthrough medical devices and IVDs under MDR and IVDR. Learn what manufacturers need to know to benefit from early designation, lifecycle evidence flexibility, and post-market strategies.

The European Commission released a draft Implementing Regulation aiming to standardise Notified Body practices under MDR and IVDR, enhancing transparency, timelines, and cost predictability.

Release 3.22 of the EUDAMED UDI/Devices User Guide provides updated guidance on MDR and IVDR device registration, UDI requirements, EMDN codes and lifecycle management for manufacturers.

The FDA has released updated draft guidance on the eCopy Program, clarifying current requirements for electronic device submissions. As eSTAR becomes the new standard, understanding when eCopy rules still apply is critical for medical device manufacturers.

The European Commission has published the results of its second survey of Economic Operators, revealing the main challenges manufacturers face under the MDR and IVDR. The findings highlight increased administrative burden, regulatory complexity and supply chain challenges, offering important insights for companies placing devices on the EU market.

The European Commission has confirmed that four core EUDAMED electronic systems—economic operator registration, UDI and device registration, notified bodies and certificates, and market surveillance—are fully functional. This triggers mandatory transition timelines and introduces significant new obligations for medical device manufacturers.

Health Canada has adopted the IMDRF Table of Contents (ToC) structure for medical device submissions, streamlining dossier preparation and supporting global regulatory convergence. The updated guidance outlines requirements for pre-market and post-market submissions and clarifies expectations for electronic filing, templates and documentation. Essential reading for manufacturers targeting the Canadian market.

The MHRA has published updated guidance on clinical investigations for medical devices, detailing the requirements manufacturers must meet when planning and conducting investigations in Great Britain. The update strengthens documentation expectations, safety requirements and regulatory oversight, making it essential for all manufacturers preparing UK submissions.

The European Commission has launched a Call for Evidence for its Digital Fitness Check, a major evaluation of EU digital legislation and its impact on competitiveness, innovation and administrative burden. This review is particularly relevant for medical device manufacturers facing overlapping digital, cybersecurity and data compliance obligations across EU rules.

The TGA has released an updated consolidated guidance on the Essential Principles for medical devices, outlining key regulatory, safety, and performance requirements manufacturers must meet to supply devices in Australia. This update strengthens expectations for risk management, clinical evidence, design and manufacturing controls, and technical documentation, reinforcing compliance obligations for medical device manufacturers targeting the Australian market.

Swissmedic has released updated guidance on the requirements for obtaining export certificates (Free Sales Certificates) for medical devices, introducing clearer rules for manufacturers on documentation, conformity evidence, product grouping, and submission procedures. The revised framework is essential for manufacturers exporting devices to global markets that require FSCs as part of their regulatory registration.

Health Canada has released Phase II of its Medical Device Establishment Licensing (MDEL) Modernization Framework, introducing enhanced compliance expectations, strengthened oversight of foreign manufacturers, updated documentation requirements and a stronger focus on post-market safety. These changes are essential for manufacturers exporting medical devices to Canada.

The FDA has released its final guidance on Computer Software Assurance (CSA) for production and quality system software, introducing a risk-based, streamlined approach to validating software used in manufacturing and quality operations. The updated framework helps manufacturers reduce unnecessary documentation, focus validation efforts on functions that impact product quality and patient safety, and accelerate the adoption of automated and digital technologies while remaining fully compliant with FDA requirements.

The FDA has issued a new draft guidance that updates the scientific principles for demonstrating biosimilarity. The document clarifies when strong analytical similarity data, supported by comparative human pharmacokinetic and immunogenicity assessments, may be sufficient to demonstrate biosimilarity without requiring a comparative clinical efficacy study. This updated approach can help manufacturers reduce development timelines and costs, while placing greater emphasis on robust analytical packages, sensitive PK study designs and a clear, risk-based justification aligned with FDA expectations.