Regulatory compliance is absolutely key to your success in both the EU and UK markets. As we all know, regulation is weighing down on manufacturers it is becoming costly and burdensome to handle in-house. Particularly since the EU has raised the standards for compliance with the introduction of Regulations (EU) 2017/745 & 2017/746. However, there … Read more
The MHRA recently published its intention to put into place a 12-month extension to the UK’s transitional arrangements. Currently, the UK MDR 2002 states that CE-marked devices will be accepted on the Great Britain (GB) market until the end of June 2023. However, this will now change. The MHRA will introduce an extension to the … Read more
The good news just keeps coming, in addition to the fantastic news of the Best Medical Device Regulatory Consultancy Award, we are also honoured to have also been nominated by Med-Tech World as the Best Med-Tech Consultancy for 2022. It seems to be a great year of recognition for Advena Limited in Malta. We will … Read more
AI Global Media Ltd has reached out to Advena to Award us with the prestigious title; Best Medical Device Regulatory Consultancy 2022. It is an honour to receive such an award and is a testament to the hard work, diligence, and desire to be excellent, not to mention the outstanding client reviews we receive. We … Read more
This document is long overdue, however, here it is! The MDCG 2022-16 Guidance on Authorised Representatives concerning Regulations (EU) 2017/745 & 2017/746. It lays out what medical device manufacturers should expect as a minimum from their appointment EU Authorised Representative. There are some interesting elements of the Regulations explained and clarified as guidance and as … Read more
As mentioned in previous editions of our monthly newsletter, Advena is taking part at MED-TECH World in Malta, it is a two-day trade show taking place on November 17th and 18th 2022. We welcome existing clients and those who wish to learn about how we can help with medical device compliance to visit us at … Read more
September 2022 saw the release of this much-anticipated document, it records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This … Read more
A revised MDCG guidance document has been released, MDCG 2021-22 Rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746. According to Article 48(6) of Regulation (EU) 2017/746 … Read more
The EU Commission has in place a draft implementing regulation, reclassifying certain active products without an medical intended purpose. Certain devices that fall into the category of High intensity electromagnetic radiation emitting equipment without an intended medical purpose are due to be reclassified to ensure an appropriate conformity assessment of those active products is consistent … Read more
Advena Ltd in Malta continues to grow and is now looking to recruit an experienced Business Administrator to join their team of regulatory specialists on a full-time basis. For more information regarding this position please visit the Jobs in Malta recruitment website: [Jobs in Malta – Business Administrator]
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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