Our first official interaction with the Italian Ministry of Health was the submission of our SRN application via EUDAMED. The Competent Authority responded with notable efficiency. Within three working days of submission, Advena SRL was issued its SRN. We are therefore pleased to confirm that Advena SRL has been assigned the following Single Registration Number: … Read more
Advena is pleased to announce the establishment of a new office in Italy, registered in Milan. Following our return from the festive break, clients will have the option to transfer their EU Authorised Representative services to our Italian office. This expansion represents an important milestone in Advena’s continued growth and reflects our commitment to strengthening … Read more
The MDCG has recently updated a guidance document concerning the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles. To offer some background to this document, the Unique Device Identification (UDI) system under Article 27 MDR ensures the traceability of medical devices by requiring manufacturers … Read more
The MDCG has recently published a guidance concerning post-market surveillance requirements for Medical Device and IVD’s. Unless otherwise specified, this guidance applies to all medical devices (MDs) and in vitro diagnostic medical devices (IVDs). To offer some background to this guidance document, Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in … Read more
The MDCG has recently published a guidance document concerning BtX, commonly known as break through devices. To offer some background to this guidance document, a medical device (MD) or in vitro diagnostic (IVD) may be designated as a breakthrough device (BtX) if it represents a significant innovation that offers a novel diagnostic or therapeutic solution … Read more
A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the … Read more
Advena understands that the Medical Device Coordination Group (MDCG) is currently revising the guidance document MDCG 2020-16 rev.4 – Guidance on Classification Rules for In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746. This update is part of ongoing efforts to enhance clarity and improve consistency across EU medical device guidance. The current revision focuses … Read more
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
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