Knowledge Center

The European Commission has just published Implementing Decision (EU) 2026/197, marking a step forward for the regulatory framework governing (...)

On 30 January 2026, the European Commission published Implementing Decision (EU) 2026/193, updating the list of harmonized standards supporting (...)

Demonstrating the safety and performance of non-active surgical implants relies on rigorous preclinical data, guided by constantly evolving standards (...)

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

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

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

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

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

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

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 (...)