We are proud to announce that Advena Malta has successfully passed the ISO 13485 surveillance audit with no non-conformities. This significant achievement underscores our commitment to maintaining the highest standards for our clients within the medical device industry. We remain focused on continuous improvement and will continue to prioritize the service we offer to our … Read more
We understand that the regulatory landscape of the MDR and IVDR is constantly changing, and in order to keep up to date with the changes, we have provided a current state of play with regards to some of the most important changes to the MDR and IVDR. MDR Extension Firstly, we would like to remind … Read more
The guidance document MDCG 2021-4 has been updated. For context, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers of class D in vitro diagnostic medical devices (IVDs) are required to submit their applications to a notified body as part of the conformity assessment process. Additionally, under certain conditions, specific elements of … Read more
Pursuant to Regulation (EU) 2024/1860, the arrangements for the transfer of the surveillance from the notified body that issued the certificate to the notified body designated in accordance shall be clearly defined in an agreement between the manufacturer and the notified body designated and where practicable, the notified body that issued the certificate. In attempts … Read more
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
Advena Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 76865
Advena Services Ltd
Registered Address:
Tower Business Centre
2nd Flr, Tower Street Swatar,
BKR 4013. Malta
Reg. in Malta No. C 103067
Advena Malta (Holdings) Ltd
Registered Address:
Highdown House
Leamington Spa, CV31 1XT,
United Kingdom.
Reg. in the UK No. 13789474
Advena SRL
Registered Address:
Via Visconti di Modrone 38
20122 Milan
Italy
Company No: MI-2785259
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
© 2026 Advena Ltd