30 / 10 / 2019 EUDAMED delayed The European Commission confirmed that EUDAMED will be delayed by two years. EUDAMED’s launch will therefore be done together for medical and in-vitro diagnostic medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022. Read more »
23 / 10 / 2019 MDCG Guidance on Software Qualification and Classification On October 11th the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. Read more »
23 / 10 / 2019 First NB designation under the IVDR DEKRA Certification GmbH in Germany (DEKRA) is the first Notified Body officially designated for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). Read more »
23 / 10 / 2019 MIR v7.2 and two new Device Specific Vigilance Guidanc European Commission has posted on their website version 7.2 of the template for a Manufacturer Incident Report (MIR), and its accompanying help text on how to complete the form. This template will become mandatory as of January 1st, 2020 for incidents under the MDD/AIMDD or IVDD, or for serious incidents under the MDR or IVDR. Read more »
27 / 09 / 2019 MDCG Issues Guidance on SSCP European Commission released MDCG 2019-9 Summary of safety and clinical performance - A guide for manufacturers and notified bodies. Read more »
15 / 01 / 2019 Medica Dusseldorf - November 2019 Meet our team at the annual Medica fair in Dusseldorf on November 18 - 21, 2019!