The first edition of the Development of Medical Devices Policies was published in 2011. This second edition has been updated to reflect the global shift from the Millennium Development Goals to the Sustainable Development Goals, ensuring alignment with today’s health priorities. New sections have been introduced to address emerging public health challenges, including sustainability, digital … Read more
We are pleased to announce that Advena will be exhibiting at WHX Dubai in February. The fair will be held on the 9th to 12th February at the Dubai Exhibition Centre in Dubai, UAE. Representing Advena at the event will be our CEO & Managing Director Anthony Kirby and our Regulatory Consultant, Mr. Sam Attard, … Read more
Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators. … Read more
There has been a new notified body that have been designated under the IVDR. The new notified body: SGS FIMKO OY is from Finland. This new addition brings the total number of notified bodies under the IVDR to 19. More information about this notified body can be found using the following link
There has been a new notified body that have been designated under the MDR. The new notified body: NOTICE, storitve ugotavljanja skladnosti, d.o.o. is from Slovenia. This new addition brings the total number of notified bodies under the MDR to 51. More information about this notified body can be found using the following link
The deadline for the mandatory use of the New MIR Template has been postponed. Previously, we reported that the new MIR form would be mandatory starting November 1, 2025. However, this has now been delayed due to indications that a revised version of the form is forthcoming. The new mandatory implementation date will be four … Read more
During the last week of October, we had the privilege of exhibiting our services at United Medical Expo in Astana Kazakhstan. This event marked an exciting milestone for us — our very first visit to the Central Asian region — and it proved to be both insightful and rewarding. Throughout the exhibition, we engaged with … Read more
On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which … Read more
TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”. To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the … Read more
The MDCG has released a draft guidance document with regard to Trend Reporting, currently numbered as MDCG 2025-XX. To provide context for this release, the draft guidance document MDCG 2025-XX has been developed to explain and clarify key aspects of Trend reporting as outlined in Article 88 of Regulation (EU) 2017/745 on medical devices (MDR) … Read more
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