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
We are pleased to announce that we will be exhibiting at this years edition of MEDICA. The exhibition will be held on the 13th and 16th of November 2023 in Dusseldorf Germany. If you are interested in one of our services, or you are an existing client who would just like to meet the Advena … Read more
On the 18th July, the EU Commission published its updated Q&A document on the practical aspects related to the implementation of Regulation (EU) 2023/607 as regards the transitional provision for certain medical devices and in vitro diagnostic medical devices. We had mentioned this in our recent newsletter and it has been posted on our website. … Read more
The initial document of the Q&A, released in late March, provided guidance for the amendment to the extension in transitional provisions. This document was well received by many entities within the regulatory space. There has been an update to the Q&A document that has been released in mid-July. The document conveniently includes a change history … Read more
We are pleased to announce that we will be exhibiting at this years edition of Med-Tech World. The exhibition will be held on the 19th and 20th of October 2023 at the Mediterranean Conference Centre in Valletta. If you are interested in one of our services, or you are an existing client who would just … Read more
The conditions that are set out in Article 120 (3) of the MDR include, among others, that legacy devices must continue to comply with the AIMDD/MDD, as applicable, and that there are no significant changes in the design or intended purpose of the device. The latter criteria could be considered as quite vague and could … Read more
On the face of it, this seems simple. Manufacturers can simply self-declare and the Q&A Document states this in section 7. Furthermore, it states that such a self-declaration could be based on a harmonised template. The downfall here is no such thing currently exists. Additional evidence could be provided by Notified Bodies (NB) again by … Read more
We are pleased to announce that Advena Services Limited has successfully obtained their ISO 13485:2016 certificate from the Italian Notified Body IMQ, under the scope of MDR/IVDR Article 13 Regulatory Importer Service. Additionally, Advena Limited were also re-certified under ISO 13485:2016 by IMQ, under the scope of European Authorised Representative service, quality management, regulatory affairs … Read more
The EU have swiftly issued this Q&A document after fast-tracking Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. It’s an interesting document and some will certainly find the information helpful, but in truth, this only clarifies what is … Read more
The much-anticipated amendment regarding the extension of the MDR transitional periods and the removal of the sell-off dates of both MDR and IVDR has entered into force as of 20th March 2023. The amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the … 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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