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MDSAP.Global: GMED listed as an recognized Auditing Organization

The new official platform mdsap.global, developed by the Regulatory Authority Council behind the MDSAP, is now live. It offers manufacturers (...)

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Newsletters

Biological evaluation of gas pathways in medical devices

The ISO 10993 series provides a framework for the biological evaluation of all medical devices (MDs) that come into direct (...)

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New serious incident reporting form for medical device manufacturers (MIR 7.3.1)

The European Commission has recently published the MIR 7.3.1 form, which will be required to use from November 2025 for (...)

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Team-NB Position Paper on the European Artificial Intelligence Act (v2)

Team-NB published an updated version of its Position Paper on the European Artificial Intelligence Act. It aims to present its (...)

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Team-NB Position Paper on the certification process under Regulation (EU) 2017/746

The Team-NB Position Paper on the certification process under Regulation (EU) 2017/746 aims to provide a harmonized and detailed framework (...)

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Upcoming Key Dates for IVD Manufacturers in 2025

In this video, Tom Patten, GMED International IVDR Manager, covers some of the upcoming crucial dates for IVD manufacturers, including: May 26, (...)

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Team-NB Position Paper: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 (v3)

Team-NB published an updated version of its Position Paper “Best practice guidance for the submission of technical documentation under Annex (...)

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Post-Market Surveillance of Devices

The Post-Market Surveillance (PMS) system is an essential process for ensuring the safety and effectiveness of medical devices placed on (...)

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GMED at The MedTech Forum 2025

GMED will be at the MedTech Forum, Europe’s leading healthcare and medical technology conference. Come meet our team at booth (...)

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4th revision of MDCG 2020-16 guidance on the rules for classification of in vitro diagnostic medical devices under Regulation (EU) 2017/746

The Medical Device Coordination Group has just published the 4th revision of the MDCG 2020-16 guidance on the classification rules (...)

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Publication in the OJEU of Regulation (EU) 2025/327 on the European Health Data Space

Regulation (EU) 2025/327 on the European Health Data Space (#EHDS) and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 was published (...)

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MDSAP Program: Principles, implementation and advantages

The Medical Device Single Audit Program (MDSAP) initiative started in 2012 and has been fully operational in 2017. Since then, (...)

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2nd call launched by the European Commission for applications for EURLs on high-risk IVDs

In February 2025, the European Commission, after consultation with the Member States in the Medical Device Coordination Group (MDCG), launched (...)

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RAPS DC/Baltimore Chapter: Unlocking the Potential of MDSAP – Quality, Regulatory, and Commercial Advantages

GMED North America is hosting a RAPS DC/Baltimore Chapter in-person event on June 5, 2025, between 4:30 and 7:00 p.m. (...)

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European Commission Newsletter on medical devices | February 2025

This newsletter from the European Commission aims to provide highlights and updates from the medical devices and in vitro diagnostic (...)

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GMED at RAPS Euro Convergence 2025

GMED will be back at RAPS Euro Convergence in 2025! From May 14-15 in Brussels (Belgium), join Béatrice Lys, Technical (...)

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GMED Guides

Application for certification under Regulation (EU) 2017/745

This guide presents the key stages of the certification process under Regulation (EU) 2017/745 set up by GMED. It guides (...)

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European Medicines Agency Q&A guidance on the implementation of the MDR and IVDR update

The EMA has updated its Q&A guidance on the implementation of EU regulations for medical devices and in vitro diagnostic medical (...)

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5th revision of the MDCG 2019-6: Q&A on the requirements relating to NBs 

The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR (...)

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Latest European Medical Device Nomenclature update

The annual revision of the EMDN ensures that MD nomenclature incorporates the latest innovations, ensuring accurate classification. These updates ensure (...)

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Phthalates in medical devices: regulations and alternatives

Since the early 2000s, particularly in Europe, there has been a growing awareness of the impact of chemical substances on (...)

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Heading for 2025: Best wishes from the 4 corners of the world!

From Paris to Washington D.C., via London and Hong Kong, all our teams would like to thank you for the (...)

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MDCG 2024-16: Form and Annex for manufacturer’s information on the interruption or cessation of supply of certain MDs and IVDs

The MDCG has just published a form for manufacturers to report interruptions or discontinuation of the supply of certain IVDs (...)

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Q&A on gradual roll-out of EUDAMED

The European Commission has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (...)

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MDR & IVDR: Have your say!

The European Commission has launched a public consultation and call for evidence on the European Regulation on medical devices and (...)

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Newsletters

European Union Reference Laboratories for in vitro diagnostic medical devices

The involvement of European Union Reference Laboratories (EURLs) is a new requirement described in Article 100 of Regulation (EU) 2017/746 (...)

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First revision of the MDCG 2023-3: Q&A on vigilance terms and concepts as outlined in the Regulations (EU) 20217/745 and 2017/746

In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and (...)

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Q&A on the obligation to inform in case of interruption or discontinuation of supply of certain MDs and IVDs

The European Commission has published a Q&A on the practical aspects related to the implementation of the obligations, laid down (...)

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Guide MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices

The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the (...)

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Newsletters

“AI Act”: what requirements and deadlines for medical devices?

On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on (...)

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