UK Update- MHRA Releases New Guidance for MedTech Manufacturers
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated Clinical Investigations of Medical Devices – Guidance for Manufacturers (April 2025). This guidance clarifies compliance requirements for manufacturers conducting clinical investigations in Great Britain and Northern Ireland.
Key updates include:
Manufacturers must ensure timely MHRA notification before starting investigations, submit final clinical reports within one year of completion, and adhere to region-specific frameworks for Great Britain and Northern Ireland.
Full guidance document
MHRA Consultation: Key Takeaways on Proposed Statutory Fee Changes
From August 29 to October 24, 2024, the Medicines & Healthcare products Regulatory Agency (MHRA) held a public consultation to propose changes to statutory fees related to medicines, medical devices, and blood components in the UK. These fees aim to recover costs associated with MHRA services, following UK treasury guidelines, and reflect necessary overheads and service complexities.
Here’s a quick review of what unfolded:
In summary, the MHRA intends to adjust fees every two years to enhance predictability and financial planning for customers, although they recognize that increasing certain fees might discourage investment in the UK and impact medical device availability for patients.
As these changes roll out, companies will need to stay proactive to understand new cost implications and access valuable advisory services.
Read the full consultation report
European Updates
EUDAMED UDI Devices Guide v3.0.11 Released
The European Union has published the latest EUDAMED User Manual for UDI Devices (v3.0.11, 24 April 2025), offering essential guidance for medical device registration and compliance.
As the EU moves toward full EUDAMED implementation, these updates provide clarity for manufacturers.
UDI Device Registration Guides:
How is your team preparing for EUDAMED’s evolving requirements? Share your challenges or insights with us. We at Sushvin will be more than happy to guide you. Contact us at www.sushvin.com
Regulatory Update: European Commission Enhances Standards for Medical Device Sterilisation
Exciting news from the European Commission! The Commission Implementing Decision (EU) 2025/679, dated 8 April 2025, marks the completion of harmonization for two additional standards related to the sterilization of medical devices. This decision amends the earlier Implementing Decision (EU) 2021/1195, reflecting the latest technical and scientific advancements.
Key Highlights:
The adoption of Implementing Decision (EU) 2025/679 represents a significant advancement in the European regulatory landscape for medical devices. By harmonising additional sterilisation standards, the European Commission not only enhances patient safety but also provides clearer guidance for manufacturers and regulatory professionals. This proactive approach reflects the EU's dedication to keeping pace with scientific progress and ensuring that medical devices meet the highest standards of quality and reliability. As the MedTech sector continues to evolve, such regulatory updates are crucial in fostering innovation while maintaining robust compliance frameworks.
Read the document here.
EU Commission's AI Continent Action Plan: Shaping the Future of Artificial Intelligence
On April 9, 2025, the European Union unveiled its ambitious AI Continent Action Plan, a bold move to position the EU as a global powerhouse in Artificial Intelligence. This comprehensive initiative outlines strategic actions to harness AI's transformative potential while safeguarding democratic values and cultural diversity.
Key Highlights:
This action plan is a testament to the EU’s commitment to shaping an AI future that is innovative, inclusive, and globally competitive.
Read the full document
Team-NB Update- Important Update on the Classification of IVDs for SARS-CoV-2 Detection
Team-NB has shared a significant update regarding the classification of in vitro diagnostic devices (IVDs) intended for screening or detecting SARS-CoV-2. This update, dated 4 April 2025, reflects the latest scientific advice and regulatory considerations, ensuring that certified devices align with evolving standards for safety and efficacy.
Key Highlights Include:
This revision aligns COVID-19 tests with the latest expert guidelines, ensuring they adhere to high safety and efficacy standards. It also emphasizes the necessity for regulatory frameworks to adapt as SARS-CoV-2 shifts from an acute emergency to an endemic situation.
To read more click here.TEAM NB Releases Position Paper on IVDR Certification Process!
On April 14, 2025, TEAM NB published its Position Paper on the IVDR Certification Process, providing detailed guidance on the pre-application, application, and post-application phases for manufacturers seeking certification of in vitro diagnostic medical devices under the EU In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
Key Highlights
This consensus document aims to harmonize certification processes across Notified Bodies (NBs), reducing incomplete submissions and advancing assessments.
New IVDR Guidance Alert: TEAM NB Publishes Essential Position Paper
The wait is over! TEAM NB has officially adopted and published its comprehensive Position Paper on the IVDR Certification Process, covering all critical phases:
This landmark document provides much-needed clarity for IVD manufacturers navigating the complex EU regulatory landscape. At a time when IVDR implementation challenges persist, this guidance offers:
Sushvin Consultancy as regulatory experts specializing in Quality Assurance and Regulatory Compliance highly recommend reviewing this paper to optimize your certification strategy.
📖 Access the full position paper here
Upcoming Training Opportunity for Manufacturers! 🌟
Team-NB is hosting the 5th session of IVDR Technical Documentation Training for Manufacturers on July 3rd, 2025. This session is tailored to provide manufacturers with essential insights into the In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746.
Access thetraining document
ICH Update- Exciting Update in Pharmaceutical Stability Testing!
The International Council for Harmonisation of Technical Requirements for Pharmaceutical for Human Use (ICH) has released a draft of the Harmonised Guideline on Stability Testing of Drug Substances and Drug Products. Endorsed on April 11, 2025, this guideline marks a pivotal moment in global pharmaceutical standards. This guideline is now open for public consultation.
This draft represents a significant step toward integrating global stability testing standards, ensuring drug substances and products maintain their quality and safety throughout their lifecycle. Stakeholders are encouraged to participate in the consultation process and contribute their knowledge to shape the future of stability testing.
To read more visit here
TGA Australia: Updated Guidance on Labelling and Presentation Requirements for Listed Medicines
Exciting news for sponsors and manufacturers! The Therapeutic Goods Administration (TGA) has released updated guidance as of 9 April 2025 for labelling and presentation requirements of listed medicines. This document provides essential insights into:
This guidance is a critical resource for sponsors and manufacturers, helping them navigate regulatory requirements and maintain high standards of safety and transparency in medicine presentation.
Read the full guidance here
Indian Update- CDSCO Update: IMDR-2017 – Key FAQs Clarified!
The CDSCO – Medical Devices Division has issued Addendum No. 01 to its FAQ document (CDSCO/FAQ/MD/01, dated April 3, 2025), providing much-needed clarity on several regulatory aspects under the Indian Medical Devices Rules, 2017 (IMDR-2017).
Stakeholders, including medical device manufacturers and regulatory affairs representatives, are invited to provide feedback on the draft guidance document. Key areas for discussion include the overall clarity and content of the guidance, as well as the revamped reconsideration process.
Key Highlights:
This clarification is crucial for manufacturers, importers, and regulatory professionals navigating India's medical device landscape.
Access the full document
ISO Update: Major Update in Sterilization Standards ISO 11137-1:2025
The newly published standard marks a significant upgrade in radiation-based sterilization for medical devices. This isn't just an update—it's a game-changer for ensuring safe, effective, and compliant sterilization processes.
What’s New?
Whether you are revisiting existing protocols or validating new processes, these standard guarantees:
Precision in sterilization is essential. Now is the perfect time to update your processes and align with the latest standard!
To read more visit
Sushvin Provides UK Responsible Person (UK RP) Services
Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
If you need PRRC Services, please contact SUSHVIN for more information.
