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PFAS Chemicals in Medical Devices and the impact of the proposed PFAS restriction

Per- and polyfluoroalkyl substances, more commonly referred to as PFAS substances, make up a group of over 12,000 chemicals....Read More

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Entry into force of Regulation (EU) 2023/607 (Amendment to MDR and IVDR)

Regulation (EU) 2023/607 has officially entered into force as of 20th March 2023, following its publication in the Official Journal of the European Union...Read More

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The implementation of the future medical device regulation in the UK

On 27th April, the MHRA published an update on the implementation of the future medical device regulation in the United Kingdom....Read More

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PFAS: The Case of Fluoropolymers

Since the publication of the PFAS restriction proposal by ECHA, there has been much commentary in all affected industries, including....Read More

Regulation (EU) 2024/1860 & the Eudamed Timeline

Regulation (EU) 2024/1860 and the Eudamed Timeline  - What does it mean for you?

This much anticipated publication is relevant for all medical device and IVD manufacturers marketing, or intending to market, their devices in the EU. If you’re wondering how to interpret this publication, we’ve got the answers....Read More

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IGJ Report Emphasises Importance of PMS

As highlighted by the IGJ Post-Market Surveillance (PMS) is crucial for ensuring the quality and safety of medical devices. European regulations mandate that manufacturers implement PMS to monitor the performance and safety of their products.....Read More

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