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Showing posts tagged with: MDR

All that you need to know about Medical devices Class I

All that you need to know about Medical devices Class I

Medical devices are devices whose purpose is to benefit patients. They are usually used by doctors and healthcare providers to help them diagnose and treat patients. Despite its usefulness, they can pose a potential risk for human health. Therefore, they must be proved safe and effective. Medical devices Class I are generally not implantable invasive devices....
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It’s Official – MDR was postponed for a year

It’s Official – MDR was postponed for a year

The European Parliament voted to suspend the implementation of the MDR by one year. The decision to delay took into account the challenges of the coronavirus pandemic and the need for increased availability of vitally important medical devices across the EU while continuing to ensure patient health and safety until the new legislation becomes applicable.   On 25...
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The European Commission proposed MDR delay

The European Commission proposed MDR delay

The Medical Device Regulation (MDR) was due to become fully applicable on 26 May 2020. However, the outbreak of COVID-19 has placed unexpected pressures on economic operators, notified bodies and competent authorities. The European Commission has faced increasing pressure to implement a delay as the novel coronavirus has taken hold of Europe and much of the...
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NEW MDR: May 2020 postponed

NEW MDR: May 2020 postponed

qmsWrapper has already written about the New EU Medical Device Regulation (MDR), and what you can expect when it comes into effect. Everyone is aware that all Medical Device companies that sell medical products in Europe must hold up to the new regulation. Companies that do not follow this regulation will not be allowed to...
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5 things you must know about CE Mark

5 things you must know about CE Mark

CE mark? It’s a symbol, it’s a declaration, it’s a proof, it’s validation, it’s European. As a medical device manufacturer, you are aware of the importance of FDA approval, of course, if you are in America. If you are chasing the European market, you know about the CE mark. In case you are MedDev Start-up, planning to...
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THE NEW MDR 2020 – all you need to know

THE NEW MDR 2020 – all you need to know

  TO ALL MEDICAL DEVICE MANUFACTURERS   The New regulation (not directive anymore) is knocking on a door to Medical Device manufacturers. Transition time is running out, it’s just 6 months away. Are you ready? We will give you a few handy pieces of information that will provide you a clearer image of what is requested and help you go...
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