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
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 … Read more
In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for … 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
We are pleased to announce that we will be exhibiting at next year’s edition of Arab Health. The exhibition will be held between the 29th and 1st of February 2024 in Dubai, United Arab Emirates. At this exhibition, you will get the chance to meet the following members of the Advena Team: If you are interested in … Read more
Earlier this month, Advena participated at the Medica Trade Fair. Medica is considered to be one of the biggest Medical Trade Shows which saw a total of 5,372 companies exhibiting and a further 83,000 visiting in this year’s edition of the trade fair. Medica has given Advena a valuable opportunity to engage with existing clients … Read more
The EU Commission seemed to have confirmed a delay to the mandatory implementation of EUDAMED by posting a new draft timeline to its website. The draft timeline indicates that all six of the modules will not be in a position to undergo independent audits before Q4 of 2026, this is primarily due to the Clinical … Read more
The 12th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notified bodies available in the European Commission’s NANDO information system. The new notified body is Sertio Oy and based in Finland. … 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
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