LFH Regulatory’s December Newsletter
Laura Friedl-Hirst
Managing Director @ LFH Regulatory Limited | Regulatory Affairs I Quality Assurance I Clinical Affairs I UKCA & CE Marking I FDA I QMS I ISO 13485 I Global Registrations
As 2024 comes to a close, we’d like to thank our clients, partners, and colleagues for an incredible year. Your support and collaboration mean the world to us.
Wishing you all a joyful festive season and a successful New Year. Here’s to an exciting 2025 ahead.
Overview of the Clinical Evaluation for Medical Devices ?
CE Marking is the entry to selling medical devices in Europe, under the EU Medical Device Regulation (MDR) 2017/745. EU MDR indicates that manufacturers ‘shall plan, conduct and document a clinical evaluation’. The requirements for the clinical evaluation of medical devices are laid down in Article 61 and Annex XIV of the EU MDR.
Spreading Festive Cheer with Project Youth Cancer
This festive season, the LFH Regulatory team has been delighted to support Project Youth Cancer’s The Big Wrap initiative by wrapping presents that will bring smiles to nearly 600 young cancer patients in 43 hospital units across the UK and Ireland.
The initiative spreads festive cheer to those spending the season away from loved ones. We’re proud to be among the many Yorkshire businesses and volunteers who’ve come together to make this possible.
A Year of Reflection and Milestones
2024 has been a year of significant investment in LFH Regulatory’s future. From a comprehensive rebrand and new website to enhanced internal processes, every step has been designed to strengthen our business and elevate the support we provide to our clients.
Thank you for being part of our journey. Here’s to a new year filled with progress, growth, and shared success
Key Regulatory Changes in MedTech in 2024
Laura Friedl-Hirst, Founder and Managing Director of LFH Regulatory, shared her insights in Med-Tech Innovation about the pivotal regulatory changes for medical devices and IVDs in the UK and EU this year.
From extended transitional periods for CE-marked devices in the UK to the EU’s adoption of the AI Act, 2024 has been a transformative year for the regulatory landscape. With evolving frameworks and a growing focus on AI in medical devices, manufacturers face the challenge of balancing innovation with compliance.
Celebrating a great year in style
The LFH Regulatory Limited team celebrated in style at the Christmas Party Night at the NEC in Birmingham, and it was a night to remember. A huge thank you to our amazing team for their hard work, dedication, and the many achievements we’ve shared this year. Here’s to celebrating the season, our successes, and the exciting opportunities ahead in 2025!?
Industry insight
The team has been hard at work sourcing the most relevant changes across the regulatory landscape to keep you up to date.
EU
Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 (November 2024) EC Guidance
This document clarifies the obligations and timelines for using EUDAMED modules as part of the transition to the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
领英推荐
MDCG 2024-15: Guidance on Publication of Clinical Investigation Reports in Absence of EUDAMED
This document aims to provide guidance on the submission and publication of clinical investigation reports and their summaries while EUDAMED is not fully functional. This guidance outlines interim processes to ensure transparency.
MDCG 2024-16 - Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices
This document provides a structured template for manufacturers to report interruptions or discontinuations in the supply of medical devices and in vitro diagnostic devices (IVDs) in compliance with Article 10a MDR and IVDR as introduced by Regulation (EU) 2024/1860
Report From the Commission to the European Parliament and the Council on the operation of Article 17 of Regulation (EU) 2017/745 of the European Parliament and of the Council on single-use devices and their reprocessing The main perceived opportunities of reprocessing of SUDs by all stakeholder groups are environmental benefits, possible cost savings and a possible solution for shortages of devices. The main challenges and obstacles for the implementation of Article 17 of the MDR are the fragmented regulatory landscape for reprocessing of SUDs, the lack of resources and a scarce interest in reprocessing of SUDs from the notified bodies. Possible health risks, liability issues and lack of evidence on the reprocessing are also considered obstacles by competent authorities on medical devices and health institutions.
COMBINE programme for clinical trials and medical devices endorsed by Member States
National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration between national authorities responsible for clinical trials and medical devices, as well as the Commission, European Medicines Agency, ethics committees and stakeholders such as sponsors, clinicians, and patient representatives.
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USA & Canada
CDRH Announces Communications Pilot to Enhance Medical Device Recall Program
The pilot aims to mimize the time between the FDA’s initial awareness of and public notification of potentially high-risk medical device removals or corrections.
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices: Guidance for Industry and Food and Drug Administration Staff
The guidance describes information device manufacturers may provide when notifying the Agency of a sterilization facility site change that will be conducted according to the policy in the guidance. FDA believes that the policy set forth in this guidance may help prevent or mitigate the potential risk of supply chain disruptions or sterile medical device shortages by clarifying the regulatory landscape for devices sterilized by EtO and helping device manufacturers to quickly and proactively secure alternative locations for the EtO sterilization of devices.?
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions: Guidance for Industry and Food and Drug Administration Staff
FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.?
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Australia
Australian Regulatory Guidelines for Medical Devices (ARGMD)
The ARGMD provides information about medical device regulations in Australia
Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024
The Therapeutic Goods Legislation Amendment (2024 Measures No. 3) Regulations 2024 (the Regulations) further support the Australian Government’s vaping reforms by clarifying the circumstances in which notified vaping goods are exempt from inclusion in the Australian Register of Therapeutic Goods (the Register) but able to be lawfully imported into or manufactured, possessed or supplied in Australia.
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Standards
ISO/IEC/IEEE 26511:2018 — Systems and software engineering — Requirements for managers of information for users of systems, software, and services
This document supports the needs of users for consistent, complete, accurate, and usable information. It provides requirements for strategy, planning, managing, staffing, translation, production, and quality and process-maturity assessment for managers of information for users. It specifies processes and procedures for managing information for users throughout the product- or systems-development life cycle. It also includes requirements for key documents produced for managing information for users, including strategic and project plans. This document provides an overview of the information-management processes that are specific for the management of information for users. Read more
ISO/IEC/IEEE 26512:2018 — Systems and software engineering — Requirements for acquirers and suppliers of information for users
This document supports the interest of system users in having consistent, complete, accurate, and usable information. It addresses both available approaches to standardization: a) process standards, which specify the way that information products are to be acquired and supplied; and b) information product standards, which specify the characteristics and functional requirements of the information. As defined in ISO/IEC/IEEE 12207 and ISO/IEC/IEEE 15288:2015, the acquisition and supply activities make up the agreement processes of the software or system life cycle. Acquisition and supply of information for users and related services are specializations of those processes. Read more