New documents on EUDAMED nomenclature!

European Commission released new documents on the European Medical Device Nomenclature (EMDN) basic principles and the structure of the Italian “Classificazione Nazionale Dispositivi medici” (CND), which was selected in March 2019 as the basis for the future European Medical Device Nomenclature.

New MDCG Guidance on Cybersecurity!

The MDCG 2019-16 document, on cybersecurity for medical devices has been released. This document is intended to provide manufacturers with guidance on how to fulfil all the relevant “General Safety and Performance Requirements” set out in Annex I of MDR and IVDR with regard to cybersecurity.

New MDCG Guidance on MDR/IVDR Sampling and MDR Codes

MDCG released two new guidance documents: MDCG 2019-13 provides guidance on sampling of MDR Class IIa / Class IIb devices and IVDR Class B / Class C devices for the assessment of the technical documentation and MDCG 2019-14 is an explanatory note on MDR codes.

ISO 14971:2019 Published!

The new “ISO 14971:2019 Medical devices — Application of risk management to medical devices” was published and made available for purchase. The new revision is a very important tool in your transition to the new Medical Device Regulation (MDR) and/or In Vitro Diagnostic Regulation (IVDR).

UDI Technical Documentation

The European Commission published eight documents related to the technical specifications for unique device identifiers (UDIs).

2nd IVDR Corrigendum

The European Parliament’s Committee on the Environment, Public Health and Food Safety voted to adopt a second corrigendum to the IVD Regulation 2017/746. This second round of corrigenda (MDR and IVDR) still have to be approved by Parliament.

2nd MDR Corrigendum

The Council of the European Union has published a second corrigendum for the EU’s Medical Devices Regulation (MDR).

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 - November 2020

Meet Qarad at the biggest European Medical Device and IVD trade fair! We will welcome you at our booth November 16 - 19, 2020!


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