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April 2024

telehealth and ISO 13131

Navigating ISO 13131: challenges for MedTech manufacturers?

Knowledge & Resources /

ISO standard 13131 provides a framework for managing telehealth services as part of the medical device environment. It combines the baselines of standards for risk management and medical devices with regulatory requirements derived from the AI (Artificial Intelligence) Act, Data Act and GDPR. Laws/ regulations / guidelines: ISO 13131:2021 ISO 13485:2016 ISO 14971:2019 ISO 31000:2018 […]

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Update – MDCG 2022-9 rev.1 – Summary of safety and performance template

Regulatory Updates /

Yesterday, revision 1 of the MDCG guidance 2022-9 was published. It provides clarification regarding Summary of Safety and Performance template, especially when devices are intended to be used by lay persons only. Please make sure, that you clearly distinct the user groups in your intended purpose definition and also keep in mind: The Summary of

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MDR: New Bundestag discussion on impact on MedTech supply

Regulatory Updates /

BVMed news: On 11th April 2024, the Bundestag will discuss the impact of the EU Medical Devices Regulation (MDR) on medical device supply. This follows a motion by the Union faction, postponed from January, which calls for: – Complementing the current regulatory system – Increasing the efficiency of the system – Reform of the five-year

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