EUDAMED roundup | What’s happened and what’s next
The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR…
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MedTech news roundup July 2022
Our July MedTech news roundup includes an IVD notification FAQ from Swissmedic, MDCG guidance on interim solutions for IVDR in…
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MedTech news roundup June 2022
Our June MedTech news roundup includes a notice from the EU Commission on the EU-Swiss MRA status for IVDs, advice…
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MedTech news roundup May 2022
This month’s MedTech news includes guidance from the MDCG on significant changes under IVDR, new ordinances from the Swiss Federal…
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Leveraging Real-World Evidence in medical device regulatory submissions
Providing data from randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of…
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MedTech news roundup April 2022
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
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MedTech news roundup March 2022
This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into…
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MedTech news round up February 2022
This month’s round up covers MDCG guidance regarding IVDs, an update from the EU Commission on the IVDR implementation plan,…
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