MDCG 2024-2: Procedures for the updates of the European Medical Device Nomenclature
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 ...
The European Commission’s Directorate-General for Health and Food Safety has published MDR and IVDR Language Requirements for Manufacturers.
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 ...
Guidance Document on the Questions & Answers Regarding Clinical Investigation has Been Updated – MDCG 2021-6 Rev.1
The MDCG has updated a guidance document initially published in 2021 regarding Clinical Investigations. The guidance document is in the form of a Question and Answer and contains a plethora of different questions and answers covering a variety of different scenarios for clinical investigations. The updated document sees the addition of a number of different ...
The EU Commission Has Commissioned a Study Monitoring the Availability of Medical Devices on the EU Market
The study is focusing on two key stakeholder groups, manufacturers and authorised representatives. The outcome of which, is to effectively monitor the availability of medical devices (including in-vitro diagnostic devices) on the EU market and the insights from these two key stakeholders are deemed essential. This study will be conducted repeatedly over a three year ...
MDCG Publish Updated Position Paper – MDCG 2022-11 Rev.1
The MDCG has issued an update to a guidance document in the form of a position paper initially released in 2022 regarding a notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. The updated position paper sees the addition of a new section entitled Call to notified bodies to ...
MDR and IVDR Communication Survey
The EU Commission published a survey in August 2023, this survey is due to close by the end of November 2023. It is only intended for stakeholders who are directly impacted by the regulatory changes for medical devices. That would seem to be a great number of organisations. The object of this survey is to ...
Advena Guidance on Regulation (EU) 2023/607
This amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the limited capacity of the notified bodies. Since its introduction in March, there have been some notable updates that manufacturers should be made aware of. Advena has created a guidance document that will help ...
