In Vitro Diagnostics and Medical Devices

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News and Events
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.

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.

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).

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.

MDCG Issues Guidance on SSCP

European Commission released MDCG 2019-9 Summary of safety and clinical performance - A guide for manufacturers and notified bodies.

Medica Dusseldorf - November 2019
Medica-2019

Meet our team at the annual Medica fair in Dusseldorf on November 18 - 21, 2019!

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