Virtual Audits in Medtech – a Call for Action

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...

MDR introduction postponed to May 26, 2021

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...

Remote Audits allowed by EU Commission

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...

MDR introduction delayed in the light of the COVID-19 pandemic?

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...

MedtechVault at the MDR Support Panel Event in Berne

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...

MDR – 4-year transitional period for certain Class I devices

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...