This comprehensive online training course is specifically designed for medical device manufacturers and industry professionals seeking to understand, prepare for, and successfully navigate the evolving regulatory requirements governing the placement of medical devices on the UK market. As the United Kingdom continues to reshape its post-Brexit medical device regulatory framework, this course offers timely, practical guidance to support compliance, strategic planning, and long-term market access.
Navigating a Rapidly Changing UK Regulatory Landscape
Since the UK’s departure from the European Union on 1 January 2021, the regulatory environment for medical devices has undergone profound transformation. Manufacturers placing devices on the Great Britain (England, Scotland, and Wales) market must now comply with the UK Conformity Assessed (UKCA) marking system, which is progressively replacing the EU CE marking for most medical devices.
The pace of regulatory change is accelerating further, with major reforms to the UK medical device regulatory framework scheduled for implementation during 2025 and 2026. These reforms represent one of the most significant overhauls of UK medical device regulation in decades, affecting manufacturers, importers, distributors, conformity assessment bodies, and regulators alike.
A pivotal element of this reform agenda is the introduction of the new Post-Market Surveillance (PMS) Regulation for medical devices in Great Britain, which came into force on 16 June 2025. This regulation introduces strengthened requirements for monitoring device performance and safety throughout the product lifecycle, increasing expectations around vigilance reporting, trend analysis, and corrective actions.
Together, these developments mark a critical transition period for the medical device sector. Organizations that fail to adapt risk regulatory non-compliance, market disruption, and potential loss of access to the UK market.
Addressing Compliance Challenges for Medical Device Manufacturers
The evolving UK regulatory requirements present a range of challenges for medical device manufacturers and other stakeholders across the supply chain. Changes introduced through UKCA marking and associated reforms directly impact:
- Technical documentation and technical files
- Device labelling and marking requirements
- Logistics, supply chain management, and market access
- Conformity assessment procedures
- Post-market surveillance systems
- Interactions with UK Approved Bodies and regulatory authorities
For organizations operating across multiple jurisdictions, including the EU and Northern Ireland, the regulatory complexity is further heightened by the need to manage differences and overlaps between UKCA, CE, and UKNI marking requirements.
This training course has been developed to help participants understand these challenges in depth and to provide clear, actionable guidance on how to align internal processes, documentation, and compliance strategies with current and forthcoming UK requirements.
Course Overview and Learning Objectives
The UKCA Marking for Medical Devices Training Course delivers structured, practical insights into the UK medical device regulatory framework. Participants will gain a comprehensive understanding of the requirements for achieving and maintaining UKCA marking, while also learning how these requirements compare with those of the EU CE marking system.
By attending this course, participants will be able to:
- Understand the regulatory requirements necessary to achieve UKCA marking
- Identify key differences between UKCA and CE marking systems
- Align conformity assessment procedures to meet both UK and EU requirements
- Navigate transitional arrangements and timelines
- Address specific requirements for placing devices on the Northern Ireland market
- Prepare for future regulatory changes affecting medical devices in the UK
The course places a strong emphasis on strategic alignment, enabling organizations to not only achieve compliance but also build resilient regulatory frameworks capable of adapting to ongoing change.
Benefits of Attending
Participants attending this training will benefit from expert-led instruction and real-world insights into the UKCA marking process. Key benefits include:
- A clear explanation of UKCA marking requirements and obligations
- Practical guidance on managing transitional arrangements
- Insights into the use of standards under UK regulations
- Understanding how to register as a manufacturer and register medical devices in the UK
- Clarification of the role and responsibilities of the UK Responsible Person
- Guidance on working with UK Approved Bodies
- Detailed discussion of technical files and UK Declarations of Conformity
- An in-depth comparison of UKCA technical files versus EU technical documentation
- Practical approaches to aligning conformity assessment procedures
- An overview of the new Post-Market Surveillance regulation in Great Britain
- Analysis of UKNI marking and its implications for the Northern Ireland market
- Forward-looking insights into proposed future changes to UK regulations
Certification and Professional Development
Upon successful completion of the course, participants will receive:
- CPD certification equivalent to 6 hours, suitable for professional records
- A Certificate of Completion, recognizing participation in the training program
These certifications support ongoing professional development for regulatory and quality professionals within the medical device industry.
Who Should Attend
This course is suitable for a wide range of professionals involved in the design, manufacture, regulation, and commercialization of medical devices, including:
- Medical device professionals seeking to understand new UKCA requirements
- Regulatory affairs managers and specialists
- Medical device manufacturers
- Quality assurance and compliance professionals
- Business development and market access managers
- Professionals responsible for post-market surveillance and vigilance activities
Key Topics Covered
The training curriculum is structured to cover both foundational regulatory concepts and advanced compliance considerations. Key topics include:
- Overview of UK Medical Device Regulations and manufacturer obligations
- Detailed explanation of UK medical device regulations
- Transitional arrangements and timelines
- Use of standards within the UK regulatory framework
- UK guidance for medical devices
- UKCA marking explained, including placement of the UKCA mark
- Registration of manufacturers and medical devices in the UK
- Role of the UK Responsible Person
- UK conformity assessment bodies and approval processes
- Technical files and UK Declarations of Conformity
- Comparison of UKCA technical files and EU technical documentation
- Aligning conformity assessment procedures for UKCA and CE marking
- New Post-Market Surveillance regulation in Great Britain
- UKNI marking requirements and future outlook
- Regulatory processes in Northern Ireland
- Proposed future regulatory changes
- Interactive workshop featuring a case study on obtaining the UKCA mark
- Workshop feedback session and live Q&A
Expert Speaker
The course will be delivered by Dr. Tina Amini, an experienced regulatory and pharmaceutical expert.
Dr. Amini is a qualified pharmacist and holds a PhD in Pharmaceutics from Aston University. She joined Lloyd’s Register in 2018 as a Senior Technical Specialist, following several years at BSI, where she served as Lead Pharmaceutical Expert and Combination Product Specialist.
With extensive experience in the classification of borderline products and consultation processes involving multiple EU competent authorities, Dr. Amini brings deep practical insight into device and drug-device combination regulation. Prior to working with notified bodies, she spent more than 17 years in the pharmaceutical industry, contributing across a wide range of disciplines and supporting products from early discovery through to commercialization.
Preparing for the Future of UK Medical Device Regulation
As the UK medical device regulatory framework continues to evolve, organizations must take proactive steps to ensure compliance, maintain market access, and manage regulatory risk. This training course provides a valuable opportunity for industry professionals to deepen their understanding of UKCA marking requirements, strengthen regulatory strategies, and prepare for the next phase of regulatory reform.
The UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course offers a timely, authoritative, and practical learning experience for those operating in an increasingly complex regulatory environment.
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