UK Update-
Navigating the Medical Devices (Amendment) (Great Britain) Regulations 2025
The UK is transitioning to an independent regulatory framework for medical devices, ensuring continuity and compliance post-Brexit. With several EU-derived regulations scheduled to expire in May 2025 which may lead to compliance gaps for manufacturers and healthcare providers.
However, the UK government after following a public consultation decided to retain four key pieces of assimilated EU law, preventing regulatory uncertainty.
Four key pieces of EU law retained are:
Reasons for retention
The Secretary of State conducted a public consultation, where most respondents supported retaining these measures. The consensus was that removing these regulations prematurely could lead to gaps in oversight and potential risks to patient safety.
Impact on Medical Device Manufacturers
Next steps for manufacturers:
European Updates
New Mandatory Manufacturer Incident Report (MIR) Form v7.3.1 Effective November 2025 Under MDR & IVDR
The European Commission has published the new Manufacturer Incident Report (MIR) form, version 7.3.1, which will become mandatory from November 2025. This update is crucial for manufacturers operating under the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Key Highlights:
Manufacturers are encouraged to familiarize themselves with the new form and update their internal processes accordingly to ensure compliance with the upcoming requirements.
Team NB- A Manufacturer’s Guide to IVDR Compliance – TEAM NB Position Paper Insights
The In Vitro Diagnostic Regulation (IVDR 2017/746) introduced stringent requirements for manufacturers, making compliance and certification more complex than before. Navigating IVDR compliance is a challenge for manufacturers, with rigorous documentation and certification demands slowing down market access. TEAM NB's latest Position Paper offers a practical solution—streamlining evidence requirements and optimizing Notified Body processes to ease compliance burdens.
Key takeaways:
TEAM NB’s insights can reduce confusion and provide a smoother certification experience for manufacturers. This could mean fewer delays and a more predictable route to compliance. Understanding this position paper is essential for anyone involved in IVDR certification and manufacturing.
Checklist for MDR Technical Documentation Submission
The Annex A Checklist for MDR Technical Documentation Submissions provides a structured format for manufacturers to ensure compliance with EU MDR (2017/745). This checklist outlines the essential requirements for submitting technical documentation to a Notified Body, helping streamline the certification process and avoid delays.
Key Sections in the Checklist:
Manufacturers must complete the checklist accurately, ensuring all referenced evidence is attached.
FDA Releases Draft Guidance on Electronic Submission Templates for Medical Device Q-Submissions.
On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Electronic Submission Template for Medical Device Q-Submissions.
This guidance introduces the use of the electronic Submission Template and resource (eSTAR), an interactive PDF form which is designed to guide applicants through the preparation of comprehensive medical device submissions. The aim of this draft guidance is to streamline Pre-Submissions (Pre-Subs), enhancing consistency and efficiency in the regulatory review process.
Key Highlights:
FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities
The U.S. Food and Drug Administration (FDA) has announced a major policy shift, expanding unannounced inspections at foreign manufacturing facilities producing foods, essential medicines, and medical products for the U.S. market.
Industry Reactions:
Indian pharmaceutical companies, which supply a large share of generic drugs to the U.S., are closely monitoring the situation. Analysts warn that firms struggling with data integrity issues may face regulatory setbacks. Compliant companies may benefit from enhanced credibility and market trust.
TGA Updates Guidance on IVD Companion Diagnostics (CDx)
On 13 May 2025, the Therapeutic Goods Administration (TGA) released updated guidance titled “Understanding Regulatory Requirements for In Vitro Diagnostic (IVD) Companion Diagnostics (CDx)”. This update aligns Australia's regulatory framework with international standards, including those of the U.S. FDA and the EU's In Vitro Diagnostic Regulation (IVDR) .
Key Highlights:
Future Updates: The TGA plans to review the implementation of this framework within 12 months and update the guidance as necessary.
Companion diagnostics (CDx )plays a crucial role in precision medicine, helping identify patients who would benefit from therapeutic product treatments or avoid adverse reactions. The updated framework ensures consistent regulatory oversight for CDx devices used in Australia.
ABHI Regulatory Round-Up: Key MedTech Updates & Insights – May 2025 Edition
Welcome to the May 2025 edition of the ABHI Regulatory Round-Up, your go-to source for the latest updates in medical device regulations, industry events, and compliance insights. This month, ABHI covered MHRA notices, international regulatory developments, upcoming training sessions, and exclusive member offers to help you stay ahead in the evolving MedTech landscape.
UK Regulatory Updates – MHRA & BSI
GB Post-Market Surveillance Updates – A new GB-specific report form will be introduced in June 2025 and become mandatory in October 2025. Manufacturers should prepare for changes in PMS vigilance reporting.
Assistive Technology Guidance Update – Minor revisions to wheelchair classifications. Manufacturers should assess relevance to their operations.
Exceptional Use Authorisations (EUA) – Now decoupled from COVID-19, ensuring broader applicability.
European Commission Updates
Manufacturer Incident Report (MIR) Version 7.3.1 – Mandatory from November 2025 for serious incident reporting under MDR (2017/745) and IVDR (2017/746).
DNV Product Assurance AS – DNV has been officially recognized as a Notified Body under the In Vitro Diagnostic Regulation (IVDR) 2017/746. This designation increases capacity for certifying in vitro diagnostic devices, ensuring compliance with EU regulations and facilitating market access for manufacturers.
DNV offers a fully digital certification process, allowing manufacturers to manage documents online and track compliance status in real time, streamlining the certification journey.
MedTech Europe Priorities
MedTech Europe is advocating for greater integration of the medical technology sector into the future EU Life Sciences Strategy, highlighting its role in boosting competitiveness and innovation within European healthcare.
Additionally, MedTech Europe has released a Practical Guide for European Medical Device Nomenclature, providing manufacturers with structured classification systems to enhance regulatory compliance and streamline market access.
FDA Guidance & AI Initiatives
Q-Submission Program Final Guidance – Streamlining feedback and meetings for medical device submissions.
FDA Launches Elsa – A new AI-powered regulatory tool for enhanced oversight.
The U.S. Food and Drug Administration (FDA) has officially launched Elsa, an AI-powered tool which is designed to enhance agency-wide operation. This tool is aimed at streamlining scientific reviews, accelerating clinical protocol evaluations, and identifying high-priority inspection targets.
IMDRF & GHWP
IMDRF Standard Operating Procedures v2 – Revised guidelines for membership and document management.
The International Medical Device Regulators Forum (IMDRF) has released Edition 13, Version 2 of its Standard Operating Procedures (SOPs). This document outlines the procedures for revising IMDRF membership, establishing subcommittees, developing regulatory documents, and managing previously developed materials.
GHWP Annual Meeting – Scheduled for December 1-4, 2025, in Bangkok.
The 29th GHWP Annual Meeting is officially scheduled to take place in Bangkok, Thailand, from December 1-4, 2025. This event will bring together global regulatory authorities and industry leaders to discuss medical device harmonization, regulatory advancements, and international collaboration.
The Thai FDA and THAIMED will co-host the meeting, ensuring a strong regional presence and engagement
National Regulator Updates
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
