The MDCG has released a guidance document concerning EMDN codes. This document is split into three main sections and provides an overview of the actors involved in the generation and maintenance of the EMDN codes and lays out the procedures for the annual revision of the EMDN Codes as well as the procedure for ad-hoc … Read more
The first MDCG guidance document released for 2024 is concerning the vigilance systems for Specific CE-Marked devices. The aim of this guidance document is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices. This document outlines the way to report incidents and serious incidents, in accordance with Articles 87 and 88 MDR … Read more
The introduction of the IVDR came with very substantial regulatory changes to the regulatory framework for IVD’s. One of the most significant changes is the increased involvement of independent notified bodies for the conformity assessment that is proportionate to the classification of the device. Under the IVDD, only a small number of high-risk devices equating … Read more
The EU commission is proposing making some of the EUDAMED modules mandatory at an earlier stage, by Quarter 4 of 2025. Under the current legislation, EUDAMED will become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029. Under … Read more
We are pleased to announce that we will be attending Medical Fair India as a visitor. The exhibition will be held on the 13th – 15th March at the Bombay Exhibition Centre in Mumbai. Medical Fair India is India’s no. 1 exhibition and conference for healthcare and with participation from over 20 countries, this fair … Read more
The EU is made up from 27 countries, most of them having their own national language. Since there is no official language of the European Union, each member state has different requirements that would need to be respected when making a device available in a particular member state. The MDR and IVDR both contain legal … Read more
Currently, the UK MDR is based on the old EU directives, most notably the MDD, IVDD and AIMD. Although they were sufficient for the time, these legislations are becoming increasingly outdated with the advancement in medical technologies. Due to this, the MHRA intends to layout a new regulation that will be closer aligned to the … Read more
A new notified body has been designated for the MDR. The new notified body, CESKY METROLOGICKY INSTITUT (NB 1383), is based in Czechia (formally known as the Czech Republic). This new addition brings the total number of notified bodies designated under MDR to 43. More information on the notified body can be found using the … Read more
The MDCG has released a guidance document regarding exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR. This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations, and associated conditions related to the demonstration of equivalence, for implantable and class III medical devices to be placed … Read more
The EU Commission have released an overview of CAB/NBs at each stage of the designation process. The document shows the different stages of the designation process and how many organisations passed each stage. The data shows that a total of 21 and 62 organisations have lodged applications SANTE F for the IVDR and MDR respectively. … Read more
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