Knowledge Center

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

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

Regulation (EU) 2024/1689 on artificial intelligence, or the AI Act, marks a new step in the framework of artificial (...)

Many medicinal products are designed for use with a medical device or part of a medical device. Given the (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

  The entry into force and implementation of Regulations (EU) 2017/745 and 2017/746 were marked by the introduction of (...)

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

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

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

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

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

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

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

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

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

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

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

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