News

Team-NB has published the first revision of its Best Practice Guidance for the submission of technical documentation pursuant Annex II (...)

The Medical Device Coordination Group (MDCG) has made adjustments throughout the document to align its interpretation with Regulation (EU) 2023/607 (...)

We are proud to announce that GMED has been recognized by the South African Health Products Regulatory Authority (SAHPRA) as (...)

From October 7-9, 2025, in Pittsburgh, we will be attending RAPS Convergence, a major event for regulatory professionals in the (...)

Join us at the 9th Annual Medical Device Post-Market Surveillance Conference in Arlington, VA hosted by Q1 Productions where Chris (...)

The European Commission has just published its final study on the deployment of AI in healthcare systems. This analysis highlights: (...)

This document, co-authored by the executive committees of NBCG-Med and Team-NB, reflects the common vision of notified bodies on the (...)

As the EU continues to revise its pharmaceutical legislation to better address rare diseases and unmet medical needs, there is (...)

GMED first-time attending the TOPRA Symposium! We look forward to meeting you in Berlin, Germany, from 29 September to 1 (...)

The Medical Device Coordination Group (MDCG) has just published Position Paper MDCG 2025-7 on Master UDI-DI implementation timelines for: Contact (...)

Implementing Decision (EU) 2025/1324 has just been published in the Official Journal of the European Union (July 8, 2025). It (...)

The European Commission has just published Implementing Regulation (EU) 2025/1234, amending Regulation (EU) 2021/2226 on electronic instructions for use (eIFU). (...)

The Medical Device Coordination Group (MDCG) and the Artificial Intelligence Board (AIB) have jointly released this new guidance document, offering (...)

The MDCG has published a revision of the MDCG 2019-11 guidance, providing updates on the qualification and classification of medical (...)

The Medical Device Coordination Group (MDCG) has just released a Q&A document providing regulatory clarification on performance studies for in (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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