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 First IVDR Reference Labs Have Been Designated
On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these ...
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 ...
MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations. Guidance on MDSW intended to work in combination with hardware or hardware components.
It’s no secret that software has become an integral part of many medical devices on the EU market. It is estimated that a quarter of medical devices either incorporate a software or could be considered to be a medical device software in their own right. In many cases, the MDSW can only achieve its intended ...
Update to Manual on Borderline and Classification for Medical Devices Under Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices
An update to the Manual on Borderline and Classifications under the MDR and IVDR has been published. The last update, version 2, was issued in December 2022, and since then has been updated to include the following devices: Root canal irrigation solutions, Temperature sensors embedded in orthopaedic devices for compliance tracking, System intended to produce ...
EUDAMED Updated to Version 2.12.
This month sees an updated EUDAMED, version 2.12 was deployed on 20th September 2023. It is important that all actors keep informed regarding these changes and how they may affect the use of EUDAMED. The release notes detailing new and updated elements can be found here: [Release Notes v2.12] The EUDAMED user guide for Economic ...
Advena Guidance on UDI Codes
We must agree, the terminology used doesn’t help. Basic UDI-DI, UDI-DI, UDI-PI and UDI all sound very similar and could pave the way for confusion. Put simply, the Basic UDI-DI is primary alphanumeric identifier of a group of devices with the same intended purpose, classification, essential design and manufacturing characteristics, which does not appear on ...
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Although the MDR and IVDR define the terms importer and distributer and specify their respective obligations, certain aspects still remain unclear. In light of this, the MDCG has published a question and answer regarding Article 13 & 14 of the MDR and IVDR respectively, entitled MDCG 2021-27 with the aim of clarifying these aspects. The ...
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 ...
MDCG 2022-18 Position Paper – Article 97 of the MDR
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. ...
