by mtvgr | Apr 2, 2020 | News
MDR introduction delayed in the light of the COVID-19 pandemic? German medtech trade group BVMed called for a postponement until the end of the coronavirus crisis, pointing to the effect of the outbreak on already stretched notified bodies to make its case. And one...
by mtvgr | Mar 3, 2020 | Information
Need help with your European Authorized Representative? How do you secure your sensitive & confidential Technical Documentation while giving it out of hands, e.g. to your European Authorized Representative? Here’s the solution: MedtechVault is a highly secure...
by mtvgr | Feb 18, 2020 | Information
Accelerating the Conformity Assessment process Curious about how MedtechVault can help accelerating your Conformity Assessment process? Read a blog from Aligned AG for an article that also points out how to deal with the tricky OEM / Legal Manufacturer relationship...
by mtvgr | Jan 14, 2020 | News
MedtechVault at the MDR Support Panel Event in Berne The MDR Support Panel provided some insights on the implementation of MDR with a special emphasis on the technical documentation with presentations by Bassil Akra (TÜV SÜD), Michael Maier (Medidee) and Arik Zucker...
by mtvgr | Dec 19, 2019 | News
MDR – 4-year transitional period for certain Class I devices The EU Parliament officially accepted the 2nd MDR corrigendum. As no request for a vote had been made on Tuesday 17 December, the text was deemed adopted. This concerns Class I products that were...
by mtvgr | Nov 28, 2019 | News
Four-year transitional period until 2024 MDR: some Class I medical devices will get a four-year transitional period until 2024 as per 2nd Corrigendum issued by European Council. The Corrigendum on MDR (Nov. 25, 2019) states: “By way of derogation from Article 5...
