Key Insights from the Medical Technology Ireland Conference

This blog was originally posted on 8th October, 2024. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY DENISE MCDERMOTT, SENIOR REGULATORY COMPLIANCE SPECIALIST, COMPLIANCE & RISKS

Medical Technology Ireland Conference 2024

Medical Technology Ireland was held in Galway, Ireland on 25-26 September, and this year’s event included a conference delivered by international experts as well as exhibitors from across the medical technology industry. The conference included presentations by leading medical device experts on cutting-edge topics relevant in today’s rapidly evolving medical device market place.

Below we discuss some of the key takeaways from the conference.

AI in Medical Devices

The conference program included a variety of topics including Artificial Intelligence (AI) in medical devices, as well as new developments in carbon footprint reduction.

The conference began with an overview of the Medtech sector in Ireland given by the Director of Irish MedTech. AI in Medtech was discussed extensively, and the benefits and risks of AI were considered. Ethics is an area of concern in AI, as well as privacy and cybersecurity. The experts in the field agree that AI has potential but must be thoroughly implemented, and there are ethical and technical challenges. Experts agreed that AI plans are required in the same manner as cybersecurity plans, and must be capable of demonstrating safety and efficacy in medical devices. 

Overall, it is acknowledged that AI is evolving at a rapid pace and regulations must be capable of keeping up. The EU Artificial Intelligence Act, Regulation (EU) 2024/1689, establishes the EU’s first legal framework for AI and establishes harmonized rules for the market, use, and service of AI systems in the EU. It also prohibits certain AI practices and lays down requirements and obligations for high-risk AI systems. In the US, the Food and Drug Administration (FDA) issued a paper in March 2024 on ‘Artificial Intelligence and Medical Products’ regarding the development and use of AI across the medical product life cycle, and in the UK the Medicines and Healthcare products Regulatory Authority (MHRA) updated their guidance on software and artificial intelligence (AI) as a medical device in June 2024. Overall, the speakers agreed that legislation may be catching up with the developments in AI, although the pace at which this is occurring may be a concern. 

Sustainability in MedTech

The event also hosted the women in MedTech forum where the unique challenges and opportunities faced by women were discussed as well as broadening career horizons and talent development. The speakers covered challenges, but also positive steps that can be taken to guarantee a future which incorporates AI and sustainability.

New developments in carbon footprint reduction and best practice approaches for medical applications were also discussed. The benefits of sustainability in MedTech are numerous and can lead to reductions in greenhouse gas emissions, as well as savings in natural resources and reductions in waste generation. 

Overall, Medical Technology Ireland brought together manufacturers, academic institutions and government organizations in a program which included presentations by experts in the field, with an overall goal of improving the quality of life of patients through safe and effective devices. 

References

1. EU: Harmonized Rules on Artificial Intelligence, Regulation No. 2024/1689, Artificial Intelligence Act, EU AI Act
2. Artificial Intelligence and Medical Products
3. Medicines and Healthcare products Regulatory Authority (MHRA) updated their guidance on software and artificial intelligence (AI)

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