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Concept of MDR Medical Device Regulation.

MEDTECH Europe Issue Decision Making Flowchart Regarding Article 10a MDR/IVDR

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Starting from 10 January 2025, Regulation (EU) 2024/1860 introduces new requirements under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), mandating that medical device manufacturers provide information in cases of supply disruptions or product discontinuation. To comply, companies must implement structured internal processes to manage these obligations effectively. To assist … Read more

Concept of MDR Medical Device Regulation.

Various European Organisations Publish Joint Discussion Paper on the Future Governance of Medical Technologies in Europe

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This collaborative discussion paper builds upon MedTech Europe’s 2023 position paper and presents a unified perspective from the European medical technology industry, represented by MedTech Europe, AESGP, COCIR, EEAR, EUROM, and FIDE. It advocates for a reform in the governance of the European regulatory system for medical technologies. The document underscores the need to establish … Read more

Concept of MDR Medical Device Regulation.

MEDTECH Europe Issue Position Paper on Submission of vigilance reports to Notified Bodies under EU MDR & IVDR

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Vigilance reports are a critical component of the post-market surveillance (PMS) system established by the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) to ensure medical device safety. Manufacturers are required to systematically collect, analyse, and review real-world data on devices placed on the EU market. … Read more

Concept of MDR Medical Device Regulation.

UPDATE: ISO 15223-1:2021

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The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include: The updated standard … Read more

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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