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 has some exciting news, we are pleased to confirm our participation in the following exhibitions: MED-TECH World in Malta, 17th and 18th November 2022. We have secured a prime location at the main entrance, Booth S1, come to Malta enjoy the winter sun and connect with healthcare technology. Arab Health in Dubai, 30th January … Read more
The European Commission has published Commission Regulation (EU) 2022/1107 which lays down Common Specifications (CS) for certain Class D In Vitro Diagnostic (IVD) medical devices in relation to the IVD Regulation 2017/746 (IVDR). Common Specifications are a set of technical and/or clinical requirements which provide a means of complying with the legal obligations for a … Read more
Common Specifications for Certain Class D IVDs Commission Implementing Regulation (EU) 2022/1107 has been published and will come into effect on 25 July 2022 to lay down the Common Specifications for the following Class D IVDs with respect to requirements regarding performance characteristics as detailed in Sections 9.1(a-b), 9.3, 9.4(a) of Annex I of the … Read more
Advena Ltd
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EU Authorised Representative, Regulatory & Quality Consultants for Medical Devices
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