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IVDR

UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

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The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU … Read more

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Advena at Medical Fair India

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We had a fantastic time at Medical Fair India this year! It was an incredible opportunity to meet so many of our valued clients and connect with prospective new clients in the medical device industry. We always appreciate the chance to engage with manufacturers looking to bring their medical devices to the European market. The … Read more

Concept of MDR Medical Device Regulation.

EU Commission has Released Draft Regulation regarding UDI Assignment for Certain Medical Devices

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The EU Commission has published the draft regulation regarding the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. The aim of this regulation is to resolve the implementation issue concerning the registration of UDI-DI data elements in EUDAMED for the mentioned devices, similar to what was done for contact … Read more

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Meet Advena at Medical Fair India

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We are excited to announce that Advena will be exhibiting at Medical Fair India 2025! Medical Fair India is India’s no. 1 exhibition and conference for healthcare. This years edition marks the 30th anniversary of Medical Fair India and is being held in India’s capital New Delhi. If you are interested in one of our … Read more

EU Publishes Guidance on AI Act

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The EU has recently published a guidance concerning the AI Act. The guidelines on defining AI systems clarify the practical application of the legal concept established in the AI Act. By providing these guidelines, the European Commission aims to assist providers and other relevant stakeholders in determining whether a software system qualifies as an AI … Read more

Concept of MDR Medical Device Regulation.

UPDATED: MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies

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The guidance document MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies has been updated. To offer some background to this document, initially released in 2019, this guidance document was released to provide a compilation of questions and answers regarding the requirements for notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) … Read more

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Advena in Dubai

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As many of our readers are aware, during the end of January and beginning of February, Advena had the opportunity to visit a number of fairs being held in Dubai: Arab Health, Medlab Middle East, and AEEDC. These prestigious exhibitions provided an excellent opportunity for us to connect with industry leaders, explore the latest innovations, … Read more

Concept of MDR Medical Device Regulation.

UPDATE: MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746

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The MDCG guidance document MDCG 2023-3 has been updated. Originally published in 2023, this document aims to clarify key terms and concepts outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a shared understanding of these terms … Read more

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Advena at Arab Health 2025

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Attending Arab Health 2025 in Dubai was an exceptional experience, offering a unique platform to connect with a diverse array of manufacturers from around the world. The event facilitated meaningful interactions, allowing us to assist numerous companies in navigating the intricate landscape of EU regulations. For those who were unable to meet with us at … Read more

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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

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