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July 10, 2020

EU publishes sector specific guidance on EU-UK relation change end of the year. What’s relevant for devices?!

The European has adopted yesterday a Communication to help national authorities, businesses and citizens prepare for the inevitable changes that will arise at the end of the transition period of the EU and UK in the Brexit separation process. Changes will occur to cross-border exchanges between the EU and the UK as of 1 January 2021– irrespective of whether an agreement on a future partnership has been concluded or not.
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July 10, 2020

FAQ Friday: Answers to your questions about PRRC

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful. 🔎 In this weeks vlog, Peter Reijntjes answers the question if the role of PRRC needs to be established and implemented at DoA when a manufacturer makes use of the transitional provisions.
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July 09, 2020

On-demand Webinar: Clinical Evaluation Requirements for NMPA

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July 06, 2020

EU commission survey on COVID-19 Notified Body services – a surprising story

The European Commission came through with their promise to provide more information on COVID-19 related product assessment by Notified Bodies. They conducted a survey under notified bodies in charge of the certification of COVID-19-related medical devices and IVDs and published a report on their findings.
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July 03, 2020

FAQ Friday: Answers to your questions about clinical investigation for class lll devices

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful.🔎 In this weeks vlog, Jasmin Hunter answers the question if you can certify legacy class lll devices under the MDR without doing a clinical investigation.
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