New Update From MHRA On UK Medical Device Regulations
On December 11th, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). This updated roadmap provides additional clarity for the industry on the intended dates for the completion of consultations, delivery of legislation, and subsequent implementation of reforms to the regulatory framework for medical devices and in vitro medical devices (IVDs) in Great Britain.
Key Highlights:
New Regulations for Post-Market Surveillance: The most progressed work package, with the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 introduced before the UK Parliament in October 2024. Industry can expect these requirements to come into force in summer 2025.
New Regulations for Pre-Market Requirements: Consultations on the new legislation will continue until April/May 2025, with the first insight into the substance and form of the eventual legislation expected between May-July 2025. Implementation is anticipated in early 2026.
Policy Development: This tranche will be completed between now and Q3 2025, encompassing the development and publication of guidance on various regulatory areas, including exceptional use authorization, early access and innovation, health institution exemption, and a specific IVD roadmap.
Software, AI, and Digital Mental Health Products: Guidance on topics relevant to software as a medical device, including Good Machine Learning Principles, artificial intelligence, cybersecurity, and digital mental health tech.
Transition Periods:
The MHRA is closely monitoring the EU review of the EU MDR and IVDR alongside the UK MDR process.
Australia Updates
The Therapeutic Goods Administration (TGA) has released an updated guidance document: Use of Market Authorisation Evidence from Comparable Overseas Regulators and Assessment Bodies for Medical Devices (including IVDs)
Published: 20 August 2018 | Last Updated: 23 January 2025
This guidance is a significant step forward in streamlining our medical device certification and registration processes. By leveraging assessments from comparable overseas regulators, we can:
What does this mean for you?
If you're a manufacturer, supplier, or sales professional in the medical device industry, this update could significantly impact your product's journey to market. It's essential to:
By embracing these changes, we can collectively enhance healthcare outcomes by ensuring patients have timely access to safe, effective, and cutting-edge medical devices. Let's continue to push the boundaries of innovation and make a real difference in people’s lives!
EU Updates
Update on EU Packaging Regulations!
The European Union has published Regulation (EU) 2025/40 on Packaging and Packaging Waste (PPWR) on 22 January 2025, set to apply from 12 August 2026.
This regulation repeals the existing Directive 94/62/EC and introduces more stringent, circularity-oriented obligations. Unlike the previous directive, PPWR will be directly enforceable in all EU Member States, fostering harmonization of packaging-related legislation across the EU. However, it remains to be seen whether Member States will utilize some flexibility offered by the regulation to adjust the requirements to their national ambitions.
Key Highlights:
What Does This Mean for Us?
For manufacturers, suppliers, and sales professionals in the packaging industry, this regulation is a game-changer:
Future Opportunities:
While the legislative work on this regulation has concluded, the European Commission will now elaborate a wide array of implementing and delegated acts. These will ultimately frame the scope of the regulation’s requirements, such as recyclability and reusability criteria, labeling requirements, and reuse targets. This is a major opportunity for further dialogue between the Commission and stakeholders. Key engagement and advocacy strategies can deliver real results where implementation and compliance may pose challenges to future business operations.
By embracing these changes, we contribute to a more sustainable future and strengthen our commitment to environmental responsibility.
Let's lead the way in innovation and sustainability within the packaging industry!
Read more about the regulation and join the discussion on how we can collectively adapt and thrive under these new guidelines.
Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices
Big News in Health Technology!
Today marks a significant advancement in the health technology sector. The European Commission has adopted an implementing regulation for joint scientific consultations on medical devices and in vitro diagnostic medical devices under the Health Technology Assessment (HTA) Regulation.
Key Highlights:
Joint scientific consultations allow health technology developers to obtain guidance on clinical evidence required for subsequent joint clinical assessments. This step streamlines the development and assessment process, ensuring better guidance and improved health technologies for all.
The HTA Regulation, applicable since January 12, 2025, is set to foster collaboration and innovation in the healthcare landscape. This marks the fifth implementing act under the HTA Regulation, emphasizing the European Commission's commitment to enhancing health technology development.
Let's celebrate this milestone towards a more efficient and effective healthcare system!
The Future of AI-Enabled Health: Leading the Way
The World Economic Forum (WEF) has released a compelling white paper titled "The Future of AI-Enabled Health: Leading the Way" in January 2025. This document delves into the transformative potential of artificial intelligence in healthcare and highlights the critical transitions needed to fully realize its benefits.
Key Takeaways:
For more detailed insights, check out the full white paper here
MDCG 2024-7 Rev. 1 Released
The Medical Device Coordination Group (MDCG) has published the new Revision 1 for MDCG 2024-7, the Preliminary Assessment Review (PAR) template for the Medical Device Regulation (MDR) (Regulation (EU) 2017/745). This update, released in January 2025, aims to streamline and enhance the assessment review process for medical devices in the EU.
Key Highlights:
This revision marks a significant step forward in ensuring the safety and efficacy of medical devices. Stay informed and ensure your devices meet the latest regulatory standards!
ISO 10993-4:2017/Amd 1:2025 Released!
Exciting news for the medical device community! The latest amendment, ISO 10993-4:2017/Amd 1:2025, focusing on the selection of tests for interactions with blood, has been published. This update provides essential updates and clarifications to ensure the safety and efficacy of medical devices in contact with blood.
Key Highlights:
This amendment ensures that testing conducted according to prior versions remains valid, and no additional testing is recommended for devices with a history of safe clinical use. Stay informed and ensure your devices meet the latest standards!
Saudi Food and Drug Authority (SFDA) Updates
The Saudi Food and Drug Authority (SFDA) has published a comprehensive document outlining the requirements for inspections and quality management systems for medical devices. This document aims to ensure compliance with the Medical Devices Law and its regulations.
Key Highlights:
For more details, you can read the full document here.
