Course overview
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.
CPD Hours: 6
Course Content
- Day 1
- Welcome and introduction
- UK Medical Device Regulation and your obligations
- UKCA marking explained (placement of UK CA mark)
- Technical files and UK declaration of conformity
- UKNI marking and the future
- Workshop - case study on obtaining the UKCA mark
- Workshop feedback
- Q&A
Speakers
Tina Amini
Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at bsi Notified Body, where she was responsible for Device Drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management System (QMS) as the lead auditor.
Tina has extensive experience of regulatory expertise for CE marking of medical devices, and has been involved in the classification of borderline products and consultation process with several EU competent authorities and EMA for device/drug products.
Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry in a variety of disciplines where she took products through from discovery to commercialisation.
