The Latest Regulatory News
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
Welcome to the October edition of the LFH Regulatory Newsletter. This month, we’re excited to explore the newly introduced AI Act and its implications for medical device manufacturers. As AI technologies continue to evolve, understanding this framework is crucial for staying compliant and competitive in the industry.
In addition to our feature article, we have important company updates, including highlights from our recent team-building event aimed at enhancing client relations. We also provide the latest regulatory insights from around the globe, ensuring you’re informed about changes that may impact your operations.
What is the AI ACT?
And what does it mean for medical device manufacturers?
It feels like in the past couple of years, everyone has been talking about AI! But is it about time the Regulations caught up with the ever evolving and advancing medical device technologies.
The AI Act 2024/1689 is a legal Framework on Artificial Intelligence, which follows a risk-based approach, approved in May 2024.
It provides legal certainty and ensures the protection of fundamental rights. The AI Act aims to promote development and innovation of safe and trustworthy AI while encouraging its uptake across the EU in both the private and public sectors. Innovation encourages the use of AI regulatory sandboxes, which enable a controlled environment for development, validation and testing in real world conditions.
100 percent customer satisfaction?- This month, our entire team gathered in London for an inspiring team-building event focused on enhancing our project management skills and client relations. We explored strategies for managing client expectations and discussed ways to improve efficiency and effectiveness. Our commitment to customer satisfaction remains our top priority, and we aim for 100% client satisfaction by creating positive experiences that keep our clients engaged. Collaboration was essential as we brainstormed how to better meet our clients' needs while fostering a culture of accountability and progress within our team.
LFH Regulatory to attend MEDICA to provide global healthcare innovators with expert guidance on navigating UK and EU Markets
Once again, the?LFH?team will be exhibiting at MEDICA 2024 to provide invaluable insights and support to healthcare innovators facing the complexities of the UK and EU markets.
MEDICA is one the largest medical trade fairs in the world and will be held from 11th to 14th November in Düsseldorf, Germany, attracting over 5,300 exhibitors and 83,000 visitors from nearly 70 countries.
Throughout the exhibition?LFH?Regulatory will be located in the UK Pavilion. If you are there, come and say hello to us.
LFH in the media
We are delighted to have one of our thought leadership articles published in the latest edition of Medical Plastics News.
As regulatory requirements evolve, understanding Regulatory Intelligence is crucial for businesses in the medical device sector.
领英推荐
But what is it? Simply put, Regulatory Intelligence is a systematic approach to collecting and analysing information about regulatory requirements affecting the development, manufacturing, and distribution of medical devices.
LFH?Regulatory Joins Forces with Project Dragon to Support Youth Cancer
LFH?Regulatory is delighted to announce its partnership with Project Dragon, a corporate club designed to demonstrate companies’ commitment to the future of Project Youth Cancer and its vital work with teen and young adult cancer patients.
Project Youth Cancer’s mission is to change the way young people experience cancer. They aim to ensure that all teenagers and young adult cancer patients and ex-patients have access to comprehensive support, including free counselling when needed.
Industry insight
Our eagle-eyed team has been hard at work sourcing the most relevant changes across the regulatory landscape to keep you up to date.
Australia
Refinements to the Personalised Medical Device Framework v3 - Guidance to assist sponsors and manufacturers comply with new regulations. ?MORE
Europe
MDCG 2021-25 Rev. 1 Regulation (EU) 2017/745. MORE
Standards List? Regulation (EU) 2017/745 on medical devices - Summary list of titles and references of harmonised standard. MORE
Standards List ?Regulation (EU) 2017/746 on In vitro diagnostic medical devices - Summary list of titles and references of harmonised standard.?MORE
MDCG 2024-11: Guidance on qualification of in vitro diagnostic medical devices. MORE
Standards
ISO/TC 76 published ISO/TR 8417:2024 - Risk Management of partculate contamination for devices with intravascular access.