The MDCG has updated a guidance document initially released in 2021 regarding Article 13 and 14 of the MDR and IVDR concerning the obligations of importers and distributers. The updates that have been published in this revision include the addition of a number of questions. These include: The updated guidance document can be accessed using … Read more
The MDCG has released a guidance document relating to the equivalence for Annex XVI products, commonly referred to as Devices Without a Medical Intended Purpose. This is the second guidance document that has been released this month concerning Annex XVI devices. To offer some background to this guidance document, the MDR provides a possibility to … Read more
The MDCG has released a guidance entitled MDCG 2023-5: Guidance on qualification and classification of Annex XVI products. This guidance is one of two new guidance’s issued by the MDCG regarding Annex XVI products during the month of December. This guidance document provides elements useful for the qualification of a product as a product without … Read more
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 … Read more
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 … Read more
November sees the addition of three new notified bodies designated under the Regulation (EU) 2017/745 (MDR). Two of these notified bodies are from Türkiye and one is from the Netherlands. These are listed below: These new additions bring the total number of notified bodies designated under the MDR to 42. More information regarding the notified … Read more
The EU Commission has updated the current state of MDR/IVDR applications with the notified bodies. The results have been documented in a .pdf power point which is split up into 3 sections: About the study and survey, Survey results for medical devices, Survey results for in vitro diagnostic medical devices. From the results, one can … Read more
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 … Read more
A revision to the MDR has been published by the EU in which they intended to streamline the UDI requirements for certain products, starting with contact lenses. This new revision sees an easing of the UDI requirements for contact lenses and hence a reduction in the associated administrative burdens by allowing for manufacturers to assign … Read more
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 … Read more
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