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ARTICLE · 28 JANUARY 2025

EU Directive on Liability for Defective Products: implications for medical device producers in Australia

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Directive provides a timely warning to Australian manufacturers to review their medical and pharmaceutical product standards.

AustraliaConsumer Protection
Anna Ross
Anna Ross
Eugenia Kolivos
Eugenia Kolivos
Jim Micallef
Jim Micallef
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A new EU Directive could have widespread implications for Australian manufacturers of medical and pharmaceutical products supplied within the EU. The Directive significantly lowers the bar for the bringing of legal claims that increases the risk of Australian manufacturers being sued in the EU.

The Directive provides a timely warning to Australian manufacturers to review their medical and pharmaceutical product standards and ensure they are protected against the increased risk.

Background

On 8 December 2024, the new product liability Directive (Directive (EU) 2024/2853) adopted by the Council of the European Union on 10 October 2024 came into force. Member States are required to transpose the Directive into national law within two years.

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