Since 1 January 2021, the landscape for placing medical devices on the UK market has undergone significant change. With further major reform to the UK’s regulatory framework for medical devices scheduled for 2025 and 2026, the sector is entering a critical period of transition. A key milestone in this reform is the introduction of a new Post-Market Surveillance (PMS) regulation for medical devices in Great Britain, which came into force on 16 June 2025.
These developments present growing challenges for medical device manufacturers, regulators, and conformity assessment bodies alike. The evolving requirements will directly impact technical documentation, labelling, logistics, and overall regulatory compliance.
This course, designed for medical device manufacturers, provides essential guidance to help stakeholders understand and navigate the UK Conformity Assessed (UKCA) marking process in the context of these regulatory shifts, ensuring readiness, compliance, and strategic alignment in an increasingly complex regulatory environment.
Benefits of attending
- Understand the requirements to achieve UKCA
- Know the differences between UKCA and CE marking
- Learn how to align your conformity assessment procedures to meet UKCA and CE marking requirements
- Consider the requirements for the Northern Ireland market
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Course Content
UK Medical Device Regulation and your obligations
- The UK medical device regulations explained
- Transitional arrangements
- The use of standards in the UK
- UK guidance for medical devices
UKCA marking explained (placement of UK CA mark)
- Registering as a manufacturer to sell medical devices in the UK
- Registering medical devices in the UK
- The role of the UK responsible person
- UK conformity assessment bodies
Technical files and UK declaration of conformity
- UKCA technical file versus EU technical documentation, differences and similarities
- Aligning your conformity assessment procedures
- New Post-market surveillance regulation for medical devices in Great Britain
UKNI marking and the future
- The process in Northern Ireland
- Proposed future changes to UK regulations
Workshop - case study on obtaining the UKCA mark
Workshop feedback
Q&A
Course Provider
Ms Tina Amini ,
Pharmacist ,
Aston UniversityDr. Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined Lloyd’s Register as Senior Technical Specialist in 2018. She has previously worked at BSI as the lead Pharmaceutical Expert and Combination Product Specialist for several years.
Tina has been involved in the classification of borderline products and consultation process with several EU competent authorities for device/drug products. Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry for over 17 years in a variety of disciplines where she took products through from discovery to commercialisation.
Who Should Attend
- Medical device professionals who wish to gain knowledge and understanding of the new UKCA requirements
- Regulatory affairs managers
- Medical device manufacturers
- Business development managers
