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
The limited capacity of the Notified Bodies is no secret and is expected to be further affected due to the newly accepted amendment. This can have a substantial effect on the response times and availability for work of the Notified Bodies, which ultimately means that the manufacturer must wait longer than usual for conformity assessments. … Read more
In early January, the EU commission put forward a proposal to extend the transition period for certain medical devices and the removal of the sell-off date for IVDR devices due to concerns of medical device shortages and notified body capacity. In February, the EU parliament has voted by a landslide in favour of the proposal … Read more
Advena is pleased to confirm our return to Arab Heath on January 30th – 2nd February 2023 we will be located in Hall 7 C70. Giving us a fantastic opportunity to meet and greet existing clients and of course the potential of forming new relationships. If you are interested in our EU Authorised Representative service … Read more
Toward the end of December 2022, the MDCG published a position paper aimed at providing a common understanding and approach to the application of Article 97 of the MDR. Giving some hope concerning devices that were certificated under the MDD but have expired since May 2021 or will expire before an MDR certificate is issued. … Read more
Following on from last month’s announcement of our nomination we were honoured to be awarded the prestigious title Best Med-Tech Consultancy for 2022. The award ceremony on the evening of November 18th, 2022, recognised so many companies and individuals who have made a positive contribution to our industry it was truly humbling to be part … Read more
Advena Services Limited (ASL) is pleased to announce the launch of a much-needed service. Many clients who use Advena Limited as their EU Authorised Representative have asked on a number of occasions if we can also take on the regulatory responsibilities of Article 13. These previous requests have in the past been unfortunately declined due … Read more
Advena Limited is pleased to announce the creation of a new Group Company, incorporated very recently in Malta and owned by Advena Malta (Holdings) Limited in the UK. We are therefore pleased to introduce Advena Services Limited (ASL). This new group company will take on new business that cannot be effectively taken on by its … 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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