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 your notified body.
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 Regulation (IVDR). Read the full article. About RAPS. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR (pdf).
MedtechVault presented at MedicalMountains in Tutlingen, Germany. MedtechVault helps manufactures and suppliers to maintain their OEM/OBL business model under MDR.
MedtechVault, the platform facilitating the comunication between economic operators and notified bodies went life today. MedtechVault allows your business to keep the OEM/OBL business under MDR/IVDR, while at the same time enable an efficient communication all your Economic Operators & Notified Body. You want to learn more? Get in touch with us today.
METEVA Group, the provider of MedtechVault has become a member of Swiss Medtech.
It is now only one year until the MDR will go live in Europe. Medtech Europe published and update on the status of the implementation (pdf). In the communication, seven European Associations call on the European Commission and Member States to accelerate the implementation of the regulatory system to prevent a “cliff-edge” scenario for patients, healthcare professionals, and healthcare systems in Europe.
The new regulations for Medical Devices (MDR) and In Vitro Diagnostics have been published: Swissmedic: Overview of new regulatationsMDR: PDF Download in your preferred langugeIVDR: PDF Download in your preferred languge MedtechVault can help your company to navigate your communication with your notified body.