The Outlook on MedTech Regulation
The MedTech Innovation Assembly 2023 proved to be a pivotal gathering of industry leaders, innovators, and experts, converging to explore the dynamic landscape of medical technology. Chaired by the esteemed Georgia Halston, our Group CEO, our regulation panel delved into the intricacies of the regulatory framework that governs the MedTech sector.
Our Panellists:
- Dr. Iain Charlton, Charlton Regulatory
- Kevin Kiely, Medlink UK
- Fiona Costello, Orcha
Interactive Engagement with KwizzBit:
The panel featured an interactive quiz facilitated by KwizzBit. Attendees were able to test their knowledge on various aspects of the MedTech industry, adding a layer of excitement and fostering a sense of collaboration.
Panel Discussions Highlights:
1. Regulation as a Core Component:
The consensus among the panellists emphasised the pivotal role of regulation as a core component in ensuring quality assurance within the MedTech industry. Recognising the ever-evolving regulatory landscape, the panel delved into the importance of staying up to date with changes to maintain a high standard of quality.
2. Quality Management Systems Update:
The need to update quality management systems emerged as a key theme. The panellists underscored the significance of adapting these systems to align with the latest regulatory requirements and technological advancements. A proactive approach to system updates was highlighted as essential for continued success.
3. Cybersecurity in DTAC:
Addressing a critical concern, the discussion turned to the often-overlooked aspect of cybersecurity in Design and Technical Documentation (DTAC). Panellists noted that despite assessments, cybersecurity remains a weak link, emphasising the need for enhanced measures to secure medical technologies against evolving cyber threats.
4. Evolution of DTAC:
With the recent implementation of DTAC, the panel acknowledged its significance while anticipating its evolution. The conversation highlighted that the dialogue surrounding DTAC is expected to transform in the coming years, reflecting the ever-changing nature of the industry.
5. Post-Market Surveillance (PMS):
The perpetual challenge of Post-Market Surveillance (PMS) was addressed with candour. The panel emphasised that PMS is not a new requirement but is often delayed, creating a metaphorical “cans being kicked down the road” scenario. The importance of prioritising PMS for the sake of patient safety was a central theme.
6. Testing and Provisions:
Ensuring that organisations “test what they say they do” emerged as a crucial point. The panel stressed the significance of having robust provisions in place to validate the claims made by MedTech companies, promoting transparency and accountability.
MIA 2024
The MedTech Innovation Assembly 2023 provided a platform for robust discussions, shedding light on the challenges and opportunities within the industry. As MedTech continues to advance, the importance of proactive regulatory compliance, cybersecurity, and transparent post-market surveillance cannot be overstated. That’s why we can’t wait to see you at MIA’24!
Register your interest for MIA’24!
Register Interest for MIA 2024
People who have registered interest on the MIA page for next year
Details
Grove House
Mansion Gate Drive
Chapel Allerton
Leeds
LS7 4DN
Register Interest for MIA 2024
People who have registered interest on the MIA page for next year