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...
by mtvgr | Nov 12, 2019 | News
Update by Swiss Medtech on regarding the MRA From Swiss Medtech: The Medical Device Regulation (MDR) comes into effect in less than half a year. Legal uncertainty regarding the status of Swiss medical devices after 26 May 2020 remains extremely high. It is therefore...
by mtvgr | Oct 25, 2019 | News
News The European Commission has confirmed that the introduction of Eudamed for MDR will be delayed by 2 years to May 2022 and will be done together with the Eudamed introduction for IVDR. It should be noted that it will not affect the MDR implementation deadline. See...
by mtvgr | Oct 11, 2019 | News
After having obtained designation for MDR as third Notified Body (after BSI Assurance UK Ltd and TÜV SÜD Product Service GmbH), DEKRA is now the first IVDR Notified Body. Congratulations! MedtechVault can help your company to better manage your communication with...
by mtvgr | Oct 11, 2019 | News
The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic...
