A new notified body has been designated for the IVDR. The new notified body, ISTITUTO SUPERIORE DI SANITA’ (NB 0373), is based in Italy. This new addition brings the total number of notified bodies designated under IVDR to 13. More information on the notified body can be found using the following link
AI Global Media Ltd has reached out to Advena to Award us with the prestigious title; Best Medical Device Regulatory Consultancy Firm 2024. It is an honour to receive such an award and is a testament to the hard work, diligence, and desire to be excellent, not to mention the outstanding client reviews we receive. … Read more
Navigating the complex landscape of EU compliance can be a daunting task for manufacturers, especially with the ever-evolving regulatory framework governing product safety. Whether you’re a manufacturer of machinery, children’s toys, or general consumer products, ensuring compliance with the latest EU directives and regulations is not just a legal obligation—it’s a commitment to safety, quality, … Read more
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
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