The LFH Regulatory Monthly Newsletter

Welcome to this months edition of LFH Regulatory’s monthly newsletter! As we race into the new year, we’re excited to share the latest industry insights, regulatory updates, and upcoming events that matter most to you.

Stay informed and ready for the changes shaping our sector in 2025.

IEC 62366-12015

Usability Testing for Medical Devices ?

Creating a usability file is a crucial part of the product development process for medical devices, including Software as a Medical Device (SaMD), in order to ensure user-centred design and safety. IEC 62366-1 is the international standard that outlines the process for applying usability testing to medical devices. It provides a structured approach to ensure that devices are designed with the user in mind and that potential risks associated with their use are identified and mitigated.

Arab Health 2025

We had a fantastic time exhibiting at Arab Health 2025 for the first time, connecting with global companies and supporting them in navigating complex regulatory markets.

A highlight of the event was our Founder and Managing Director, Laura Friedl-Hirst, delivering her presentation at the UK Pavilion “Defining Your Medical Device’s Intended Purpose – Essential Strategies for Successful Market Entry,” which underscored the vital role of defining a medical device’s intended purpose early in the design process.

Thank you to everyone who stopped by to chat with us—we enjoyed insightful discussions and look forward to continuing the conversation! If we missed you, feel free to reach out.

LFH out and about

Helen?George, Business Manager at LFH Regulatory, was thrilled to attend the Medilink Midlands event on behalf of LFH Regulatory.? This event, hosted with Health Tech Enterprise and the Science & Engineering Health Technologies Alliance (SEHTA), focused on strengthening HealthTech support across the region. It’s the second in a series of events designed to support the growing East of England MedTech Cluster.? It was great to connect with one of our clients, Whzan Digital Health and hear about many cutting-edge solutions in the MedTech space.

Industry insight

The team has been hard at work sourcing the most relevant changes across the regulatory landscape to keep you up to date.

European Union

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IVDR Transition periods - Visual

The extended timelines aim to address challenges faced by manufacturers and notified bodies during the transition, ensuring continued availability of essential diagnostic devices in the EU market. Read more

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MDCG 2021-16/ MDCG 2024-8: Annex to application form & PAR template IVDR

The Annex shows a list of documents that are to be submitted with the application. Read more

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MDCG 2021-15/ MDCG 2024-7: Annex to Application Form & PAR Template IVDR

The Annex shows a list of documents that are to be submitted with the application. Read more

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MDCG 2021-15 rev.1 - Application form for designation as a notified body or extension of the scope of designation under Regulation (EU) 2017/745 on medical devices (MDR)

This form describes the information to be submitted by notified bodies when applying for designation under the MDR or when extending their scope of designation. Read more

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MDCG 2021-16 rev.1 - Application form for designation as a notified body or extension of the scope of designation under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

This form describes the information to be submitted by notified bodies when applying for designation under the IVDR or when extending their scope of designation. Read more

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MDCG 2024-8 rev.1 - Preliminary assessment review (PAR) form template - IVDR (Regulation (EU) 2017/746)

This form is for documenting the DA's review of the CAB's application. It serves as a living document during the review process after the completeness check but only the final version should be sent to the European Commission. Read more

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MDCG 2024-7 rev.1 - Preliminary assessment review (PAR) form template - MDR (Regulation (EU) 2017/745)

This form is for documenting the DA's review of the CAB's application. It serves as a living document during the review process after the completeness check but only the final version should be sent to the European Commission. Read more

Switzerland

Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs) and the Medical Devices Ordinance

With the entry into force today of the amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO), Switzerland is implementing extended transitional periods in line with the EU Regulation. This restores regulatory equivalence with the EU. Read more

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United Kingdom

Guidance: Regulation of devices in Northern Ireland

Information about the EU Regulations and their implementation in Northern Ireland: Update to 'Clinical investigations and performance studies in Northern Ireland' section. Read more

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The Medical Devices (Post-Market Surveillance Requirements) (Amendment (Great Britain) Regulations 2024: Standardised format for periodic safety update report (PSUR)

This document provides a standardized structure for creating Periodic Safety Update Reports (PSURs), ensuring consistent and comprehensive reporting of post-market safety and performance data for medical devices. Read more

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The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation

This document provides guidance on the interpretation of certain requirements in this Statutory Instrument (SI) 2024?No. 1368. Read more

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Guidance: Post-Market Surveillance (PMS) obligations by medical device type

These requirements do not apply to devices subject to clinical investigation, performance evaluation or exceptional use authorisation in Great Britain. Read more

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Post Market surveillance requirements for medical devices: summary of changes

This shows a summary of main changes introduced with the statutory instrument (SI) and associated guidance. Read more

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies

While the manufacturer is required to produce a PSUR for all devices it places on the Great Britain (GB) market unless regulation 44ZL applies, approved bodies only have obligations regarding PSUR under regulation 44ZM when they have a contract with a medical device manufacturer. Read more ?

Medical Devices: examples of reportable incidents

Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK. Read more

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USA

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act: Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA or Agency) is issuing this guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. 116-136 (March 2020). Read more

Premarket Approval Application and Humanitarian Device Exemption Modular Review: Guidance for Industry and FDA Staff

This document supersedes and replaces, “A Modular Approach to PMA Review,” dated January 29, 1998, and “Guidance for the Medical Device Industry on PMA Shell Development and Modular Review,” dated November 6, 1998. Read more