This Months 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
This month we’re diving into key insights and updates from the world of medical device regulation, quality management, and innovation. Whether you’re navigating ISO 13485 and CE Marking audits, seeking guidance on regulatory intelligence, or celebrating success stories, we’ve got you covered.
Here’s what you’ll find in this issue:
We hope you find this month’s newsletter informative and inspiring. Thank you for being part of our journey to simplify regulation and support innovation.
Read on and let’s make regulatory success achievable together.
ISO 13485 and CE Marking Audits
How to Succeed
If you’re a medical device manufacturer, passing ISO 13485 and CE Marking audits is a critical milestone. These audits are not just about compliance – they’re about demonstrating that your products are safe, effective and ready for market. Let’s walk through what to expect from these audits, how they’re connected and tips to prepare.
LFH creates modules for Innovation Academy
We’re delighted to be partnering with?Health Innovation East Midlands?to support the launch of three new, FREE learning modules in their?Innovation Academy—a program designed to guide healthcare innovators on their journey to market. These modules, created by our Managing Director Laura Friedl-Hirst, cover essential regulatory topics, including:
The Innovation Academy is committed to empowering innovators by helping them navigate the complexities of the healthcare landscape and bring new solutions to the?NHS?and the broader healthcare ecosystem.
Meet Our New Starters:
Alexander Madell & Faiza Jabeen
We are thrilled to introduce two new members of the LFH Regulatory team who bring a wealth of expertise and passion to their roles. Please join us in welcoming Alexander Madell, our new Quality Assurance and Regulatory Affairs Consultant, and Faiza Jabeen, our new Senior Regulatory Affairs Consultant. With their extensive experience and enthusiasm for the regulatory field, they are set to make a significant impact, supporting both our clients and the continued growth of LFH Regulatory.
LFH in the news
What is regulatory intelligence?
This month Laura Friedl-Hirst, managing director at LFH Regulatory, speaks to Medical Plastics News to explore what regulatory intelligence is and how it can benefit businesses.?
Key takeaways:
领英推荐
LFH Regulatory Limited wins Eaton Smith Solicitors Business of the Month Award
We are delighted to be awarded the Eaton Smith Solicitors Business of the Month Award. This award, which recognises outstanding businesses in the community, was awarded to LFH Regulatory for its excellence in service, innovative approach to regulatory consulting, and significant contributions to its industry.
LFH on the road
This month the LFH team were in Düsseldorf exhibiting at MEDICA, one of the largest healthcare exhibitions in the world.
We were based on the UK Pavilion and attended the exhibition to provide invaluable insights and support to healthcare innovators facing the complexities of the UK and EU markets.
Many companies are bypassing the UK and Europe, opting to go straight to the USA, as they perceive the processto be too complicated.? It doesn’t have to be, and this is where LFH Regulatory can help.
Fancy a career in Regulatory Affairs?
LFH Regulatory Limited had the privilege of representing the company at University of Nottingham this month, where Zara Malik, Head of Regulatory Affairs, spoke about why Regulatory Affairs is a rewarding and fulfilling career choice. The event was aimed at master's students, offering them an opportunity to explore alternative career paths beyond research.?
Zara shared her personal journey – how she initially considered pursuing a career in research but realised that Regulatory Affairs offered not only better career prospects and a better work-life balance, but also the opportunity to utilise her scientific and analytical skills in a way that directly contributes to healthcare.? If you’re interested in learning more about Regulatory Affairs or want to hear about what it's like to work as a Regulatory Consultant at LFH Regulatory Limited, don’t hesitate to connect with us. We’re always happy to share our insights and experiences.
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.
EU
Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC
This Directive lays down common rules on the liability of economic operators for damage suffered by natural persons and caused by defective products, and on compensation for such damage. The objective of this Directive is to contribute to the proper functioning of the internal market while ensuring a high level of protection of consumers and other natural persons.??READ MORE
MDCG-2023-3 Rev. 1
Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746?. This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations. The document is written for competent authorities, economic operators and other relevant parties.?READ MORE
UK
Consultation on Medical Devices Regulations?
Routes to market and in vitro diagnostic devices. The Medicines and Healthcare products Regulatory Agency (MHRA) is inviting members of the public to provide their views on proposals to update the regulatory framework for medical devices. We welcome the views of patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals and the wider public on four areas: International reliance; UKCA marking; In vitro diagnostic devices; Assimilated EU law.??READ MORE
Notice The MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety.?
A consultation has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) on proposed changes to the regulatory requirements a medical device must meet before it is placed on the market in Great Britain. The consultation will close on 5 January 2025.?READ MORE
Australia
How to submit a custom-made medical device and patient-matched medical device notification - step-by-step guide v4.?
This user guide will assist you with completing and submitting a Custom-Made Medical Device (CMMD) notification and Patient-Matched Medical Device (PMMD) transition notification.V4.0: Remove transition notification content.??READ MORE