As many of our readers are aware, earlier this month we visited Medi-Pharm Expo in Ho Chi Minh City. This is the second fair that we had the pleasure of visited in the ASEAN region. This fair was interesting in the sense that it is catered to both the pharmaceutical and medical device industry, with … Read more
In a significant move to promote transparency and fairness in the medical device market, the European Commission has released a comprehensive list of notified bodies along with their published fees for conformity assessments. This initiative is expected to bring much-needed clarity to the certification process, ensuring that manufacturers, particularly small and medium-sized enterprises (SMEs), can … Read more
At the end of July, the EU Commission implemented decision (EU) 2024/2120 regarding the renewal of issuing entities who are designated for the assignments of UDI (Unique Device Identifier) for medical devices. The regulation states that the issuing entities listed in the Annex of Decision (EU) 2019/939 will be renewed for the next 5 years … Read more
We are pleased to announce that we will be exhibiting at this year’s edition of MEDICA. The exhibition will be held between the 11th and 14th of November 2024 in Dusseldorf Germany. If you are interested in one of our services, or you are an existing client who would just like to meet the Advena … Read more
The 12th of July is an important day in the world of AI as it marks the date that the AI act was published in the Official Journal of the European Union (OJEU). This makes it the first comprehensive legislative framework for the regulation of AI systems across the European Union. The EU AI Act … Read more
The proposal put forward by the EU Commission regarding the extension in transitional provisions of certain in-vitro diagnostic medical devices, gradual roll-out of EUDAMED and the obligation to inform in case of interruption or discontinuation of supply has been officially published in the Official Journal of the EU. The published regulation can be accessed using … Read more
There has been an update in the guidance document MDCG 2021-5 concerning the standardisation for medical devices. The guidance document was initially released in 2021 to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its … Read more
Persuant to question 5 of the Q&A released by the EU Commission, manufacturers need to demonstarte that the conditions for the extension are fulfilled by means of a self-declaration, similar to the form produced for the MDR extension. The self-declaration should also state the end date of the transition peroid and should clearly identify the … Read more
The EU Commission has released an informative Q&A document intended to provide guidance on the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in … Read more
There has been an update in the guidance document MDCG 2020-16 concerning the classification rules for in vitro diagnostic medical devices under regulation (EU) 2017/746. During this third revision, one can note there have been a few updates to this document. The most significant update is in the definitions section where there has been the … Read more
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