News

As we step into this new year, our teams in Paris, Washington, D.C., and Hong Kong extend their best wishes (...)

The Medical Device Coordination Group (MDCG) has released its new guidance: “Post-Market Surveillance of Medical Devices and In Vitro Diagnostic (...)

The Commission Implementing Regulation (EU) 2025/2526, published on 17 December 2025, amends Regulation (EU) 2023/2713 to correct the designation of (...)

The Revision 1 of MDCG 2025-7, published in December 2025, clarifies the key dates for implementing Master UDI-DI for contact (...)

The Medical Device Coordination Group (MDCG) has published its 2025-9 guidance on Breakthrough Devices (BtX) under the Regulations (EU) 2017/745 (...)

The European Commission has officially declared that 4 modules within the European Database on Medical Devices (EUDAMED) are now fully (...)

GMED will be attending MedFIT in Strasbourg on December 2nd and 3rd, and virtually on December 8th! MedFIT is a (...)

On October 17, 2025, the European Commission adopted Implementing Decision (EU) 2025/2078, updating harmonized standards for: Surgical clothing and drapes (...)

This reference document, developed by the Borderline and Classification Working Group (subgroup of the Medical Device Coordination Group), provides essential (...)

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 (...)