As Advena Ltd in Malta continues to grow, we are now looking to recruit an experienced Business Administrator to join our team of regulatory specialists on a full-time basis. The successful candidate will work alongside our existing team of regulatory specialists, primarily on the review and preparation of various types of documentation for submission with the Maltese … Read more
In July 2023, the European Commission introduced Commission Delegated Regulation 2023/2197, establishing specific rules for assigning Unique Device Identifiers (UDI) to contact lenses. This regulation not only outlined tailored requirements for UDI-DI assignment but also provided manufacturers with an extended timeline to comply. Commission Delegated Regulation 2025/788 has now updated these provisions. While the original … Read more
The MDCG has released a position paper regarding 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 position paper, the introduction of the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical … Read more
The European Commission has released a revised timeline for the gradual rollout of the European Database on Medical Devices (EUDAMED), reflecting the current consultation status with the Medical Device Coordination Group (MDCG) and recent policy updates. This timeline clarifies key milestones for stakeholders and provides crucial visibility into when the different EUDAMED modules are expected … Read more
There has been a new notified body that have been designated under the IVDR. The new notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. is from Poland. This new addition brings the total number of notified bodies to 18. More information about this notified body can be found using the following link
We are pleased to announce that Advena will be exhibiting at United Medical Expo in October. The fair will be held on the 29th and 30th of October at the Astana Expo IEC, Astana Kazakhstan. This is the first time we will be exhibiting in Central Asia, and we are excited to see what this … Read more
As many of our readers are aware, in July we had the pleasure of attending WHX Kuala Lumpur, a leading international exhibition for the medical and healthcare industry in the ASEAN region. The event, held in Malaysia’s vibrant capital, brought together key players from across Southeast Asia’s medical device and health tech sectors. During our … Read more
The MDCG has released a guidance document concerning the interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA). This document offers an initial set of answers to the most frequently asked questions concerning the joint application of the Artificial Intelligence Act (AIA) and … Read more
There has been an update to the guidance document MDCG 2019-11 concerning Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. originally released in 2019, this guidance document, aimed primarily at Medical Device Software (MDSW) manufacturers, offers guidance on the following: The criteria outlined in this document … Read more
The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use … 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
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