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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.

FAQ FAQ Friday Medical Device Regulations PRRC Vlog

Importing face masks into the EU? What you need to know.

Are you thinking of importing Face masks into the European Union? First, you need to know how to meet the European Regulations for Face masks, what are your challenges? And how do you ensure that the masks comply to the European Regulations? What are the differences between the different kind of masks?

Results

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.

In-Vitro Diagnostics Market Access Europe Medical Devices

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.

FAQ FAQ Friday Medical Device Regulations PRRC Vlog

On-demand Webinar: Clinical Evaluation Requirements for NMPA

Clinical Evaluation NMPA

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.

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.

Clinical Investigation FAQ FAQ Friday Vlog

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