This series of webinars provides a legal update and practical guidance on key issues relevant to medical device companies in the UK, EU and US. Broken down into four hot topics, our experts cover medical device regulation (including the EU MDR and IVDR), the impact of data and AI for medical devices, the regulation of software as a medical device, and the management of product liability risks in this space.
If you couldn't join us live, you can watch the session recordings below.
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Getting to grips with medical device regulation (EU MDR and IVDR)
Partner Alison Dennis and Associate Nick Vollers take viewers through certificate extensions in the EU (and the UK approach) and derogation applications, economic operators and placing on the market, clinical evaluation content, and regulatory change and effect on corporate acquisitions.
Understanding data and AI for medical devices
Partners Vicky Hordern and Thanos Rammos consider the key aspects of the EU AI Act and Data Act, the UK's approach to AI in medical devices and data protection form, and the pitfalls of GDPR for medical devices.
Regulating software as a medical device
Partner Alison Dennis and Associate Nick Vollers return for webinar three to explain the distinction between wellness products and medical devices, the UK's proposed approach to innovation and software devices, and the regulation of AI medical devices in the UK.
Product liability developments in the European regime
Partner Katie Chandler wraps up the series with an overview of recent medical device product liability developments, covering the two key subjects of the strict liability regime and the European Commission's proposed amendments to the Product Liability Directive.