Counterfeit medical devices in Europe: a problem with too little data

Medical devices fakes, gefälschte Medizinprodukte

Counterfeit medical devices are a problem worldwide, as inferior counterfeits endanger patients’ lives. Unlike counterfeit medicines, however, there is hardly any data or established processes and regulations to help solve the problem. Medical devices form a diverse and large group with over 500,000 products. Subsequently, they are often affected by counterfeiting or irregularly removed from […]

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Overview of the EUDAMED User Guides

EUDAMED User Guides

EUDAMED stands for European Database on Medical Devices. It was introduced as part of the Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR). Manufacturers register their products here and store all relevant data such as certificates and studies. Thanks to this database, patients can easily access information about the medical […]

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AI in MedTech

KI/AI in MedTech

With the launch of ChatGPT on November 30, 2022, artificial intelligence (AI) experienced a huge boom worldwide. Within two months, 100 million people had registered for the chatbot developed by OpenAI. The already prominent topic developed into a megatrend in a short space of time. ChatGPT and competing products such as Google’s Gemini are generative […]

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MDR preparation – How to deal with the EUDAMED postponement?

MDR Preparation

Since the Medical Device Regulation (MDR) was published in 2017, we witnessed many changes and deadline postponements. It is also likely that there will be more in the future. For medical device manufacturers, the most significant change has been the extension of the transition periods for the MDR and EUDAMED. Some medical device companies expressed […]

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Software as a Medical Device

Software as a Medical Device

Software as a Medical Device (SaMD) is a collective term for software used for medical purposes. SaMDs exist as stand-alone products and as parts of other medical devices. Their legal definition varies from country to country. For example, the Medical Device Regulation (MDR) defines them as follows: Software intended to be used alone or in […]

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Registration and Digital Marking of Medical Devices in Russia

Medical Devices in Russia

Anyone wishing to sell products in Russia, whether pharmaceuticals, spirits, or medical devices, must comply with certain regulations and, if necessary, guarantee the traceability of their products. A large-scale track-and-trace project in Russia has been transferring numerous product groups to a track-and-trace system for several years to reduce counterfeit products and illegal trade. According to […]

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