by mtvgr | Dec 16, 2020 | News
MDR introduction on May 26, 2021 – is your company prepared? MDR is coming on May 26, 2021. For Swiss Medtech Companies this also means a decision whether or not to prepare for a set-up with an European Representative (EAR) or not. Swiss Medtech has issued...
by mtvgr | Aug 21, 2020 | News
Virtual Audits in Medtech – a Call for Action In a recent Webinar, the role of virtual audits was assessed. Virtual or remote audits are currently one of the most relevant topics within the Medical Device Industry, especially in times of the corona pandemic...
by mtvgr | Apr 17, 2020 | News
MDR introduction postponed to May 26, 2021 (Swiss Medtech) On 17 April 2020, the EU Parliament adopted a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to the 26 May 2021. The regulation shall enter into force on the...
by mtvgr | Apr 14, 2020 | News
Remote Audits allowed by EU Commission See MDCG guidance how notified bodies can run audits while quarantine / travel restrictions prohibit site visits. The document clearly points out to use “the most advanced available Information and Communication...
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 | 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...
