Spotlight on medical devices

Hear from our legal experts as well as industry professionals on the latest legal developments affecting medical device manufacturers and distributors.

Engaging panel discussions will allow ample opportunities for insightful conversations and dynamic participation.

Topics will include:

An update on UK regulations for medical devices and IVDs.
Unravelling the EU regulatory matrix, providing you with a clear understanding of compliance across various directives.
The latest on AI regulation and its effect on medical devices.
Spotlight session on IVDs.
Case study insights into effectively managing adverse incidents.
Data security breaches: strategies to protect your firm's and your devices' data integrity.

专长

执业领域和服务团队

医疗监管

生命科学监管咨询

网络安全与数据泄露

行业

酒店与休闲

Hot Topics

Artificial Intelligence Act

计划

08:30	Registration and breakfast
09:00	Welcome
09:05	An update on UK regulation for medical devices and IVDs – what's new and what do you need prepare for?
09:20	Unravelling the European regulatory matrix – gain a clear understanding of the layers of requirements that apply to medical device manufacturers and their businesses, including the AI Act, AI Liability Directive, the Data Act, NIS2, the European Health Data Space, Batteries Regulation.
10:50	Morning break
11:20	Competition law for medical devices – controlling your supply chains within the constraints of EU and UK competition laws while complying with MDR economic operator requirements.
11:50	Case study insights – effectively managing adverse incidents and dealing with competent authorities and drafting FSCAs and FSNs.
12:30	Lunch
13:40	Panel discussion – the evolving approach of the FDA, the EU Commission and MHRA to regulation of medical devices. Are they getting closer, or further apart?
14:20	ESG and its implications for businesses involved in medical devices, including complying with NHS requirements including action points complying with the EU Corporate Sustainability Reporting Directive and compliance with NHS supplier requirements.

14:50	Advertising medical devices – a nuanced approach to advertising medical devices across Europe in the face of a lack of harmonised laws. International panel of regulatory lawyers
15:30	Afternoon break
15:40	Product liability under the new EU product liability directive – ushering in a new era for medical device companies selling into the EU.
16:25	Data Security Breaches - strategies to protect your firm's reputation during a cyber crisis.
17:00	Spotlight on IVDs (optional)
17:00-19:00	Drinks and canapés

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Spotlight on medical devices

专长

执业领域和服务团队

行业

Hot Topics

计划

演讲者

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