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New MDCG guidance documents!

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the obj...
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No CE marking needed!

On a regulatory level the EU allows important devices to be placed on the EU market without the CE mark relevant for the fighting of the COVID-19 crisis. Those are Products covered by Regulation (EU) 2016/425 on personal protective equipment (PPE) and medical devices covered by the Directive 93/42/E...
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Statement on Covid-19

The Covid-19 outbreak is rapidly changing lives and business practices worldwide. Increasingly stricter measures are being implemented to protect public health. During these difficult times the safety and well-being of our families, friends and colleagues are our highest priority. Authorized Represe...
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Warning – For risk class I devices!

Products, which stay class I under the MDR, must be in full compliance by May 26 2020! MDSS concern: Some clients seem to be under the impression that there was an extension given until May 2024 due to the MDR second corrigendum. This is not true. MDSS concern: Clients who have class I devices and ...
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Standards free of charge!

CEN and CENELEC make European standards freely available relevant for the crisis.  Standards are created by standard organizations who carefully draft those. It sometimes takes several years of negotiations until a standard sees the light and can be used. The European Union (EU) in general calls ou...
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For risk class I manufacturer!

  Warning: No additional  transition for risk class I products.  Products who are risk class I and stay of risk class I must fully comply to the MDR by May 2020. Please consider the MDCG guidance Guidance Notes for Manufacturers of Class I Medical Devices cover.pdf – December 2019. I...
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