We are pleased to announce the launch of our first YouTube channel, marking another step in our ongoing commitment to providing valuable resources and enhanced support to our clients. Click the following link to view our first upload: https://www.youtube.com/watch?v=au5yAfWTRYU
On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices. This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens … Read more
Clients may have noticed that our email addresses have recently changed. This transition has been implemented gradually to minimise any confusion, and we hope it has been seamless. Our new email addresses now use the domain @advenaltd.eu. Going forward, all email correspondence from our team will be sent using this updated domain. Please note that … Read more
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
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:
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Italy
Company No: MI-2785259
EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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