The Austrian National Public Health Institute is conducting a survey on behalf of the European Commission (DG SANTE/HaDEA) to collect information and data on the status of the implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/745 (IVDR). The aim of this survey is to get a realistic picture of the status of the … Read more
The first Notified Body under the Medical Device Regulation (MDR) has officially opened in Malta, marking an important milestone for both the local life sciences sector and the wider European medical device landscape. In simple terms, a Notified Body (NB) designated under the Medical Device Regulation (EU) 2017/745 is an independent, third-party organisation appointed by … Read more
ISO 10993-1:2025 has recently been published, introducing important updates to the cornerstone standard for the biological evaluation of medical devices. ISO 10993-1 plays a critical role in defining the principles and requirements for assessing the biological safety of medical devices within the broader risk management framework established by ISO 14971. The standard guides manufacturers and … Read more
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
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