Regulatory Updates
MDCG 2025-10: New PMS Guidance for MDR & IVDR
The MDCG released new PMS guidance in December 2025. Learn what MDCG 2025-10 means for your MDR and IVDR compliance strategy.
MedNet EC-REP
MDRIVDRPost-Market Surveillance+2 more
News & Regulatory Updates
Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
Updated regularly
36 Articles
Regulatory Updates
EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers
The European Commission (EC) has formally declared that the first four modules of EUDAMED - the European Database on Medical Devices - will become mandatory as of 28 May 2026.
MedNet EC-REP
Company News
MedNet EC-REP GmbH to Exhibit at WHX 2026 in Dubai – Visit Us at Booth S9.E77
MedNet EC-REP GmbH is excited to announce its participation in WHX 2026, taking place from February 9–12 in Dubai. As a trusted European Authorized Representative and compliance partner for global medical device manufacturers, we look forward to presenting our comprehensive regulatory services to an international audience.
MedNet EC-REP
Regulatory Updates
MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration.
MedNet EC-REP
Regulatory Updates
Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR
European regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) require precise definitions in technical documentation, and the distinction (or overlap) between intended purpose and intended use remains a topic of operational significance. This bulletin clarifies the regulatory definitions, their implications, and guidance interpretations.
MedNet EC-REP
Company News
MedNet EC-REP GmbH at MEDICA 2025 - Visit Us in Hall 3, Booth D43
MedNet EC-REP GmbH is pleased to announce that we will once again be exhibiting at MEDICA 2025 in Düsseldorf, the world’s leading trade fair for the medical technology industry. From 17 to 20 November 2025, you will find us at Hall 3, Booth D43.
MedNet EC-REP
Regulatory Updates
Implications of the Update to the Borderline & Classification Manual under MDR and IVDR
On 12 September 2025, the European Commission published Version 4 of the Manual on Borderline and Classification under Regulations (EU) 2017/745 and 2017/746, developed by the Borderline and Classification Working Group (BCWG). This updated manual provides revised guidance on determining whether a product is a medical device (or in vitro diagnostic device), dealing with borderline cases, and applying the classification rules under MDR and IVDR. Regulatory affairs professionals should be aware of both the new content and the practical implications for compliance.
MedNet EC-REP
Regulatory Updates
EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know
The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU). This update, outlined in the latest draft Commission Implementing Regulation, aims to expand the scope of electronic Instructions for Use (eIFU) to a broader range of medical devices, reflecting a clear preference among healthcare professionals for digital access to critical information. This article summarizes the key changes and their implications for the medical device industry.
MedNet EC-REP
Regulatory Updates
Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6
The regulatory landscape for medical devices and in vitro diagnostic medical devices is continuously evolving, with the introduction of new technologies like Artificial Intelligence (AI) adding layers of complexity.
MedNet EC-REP
Regulatory Updates
Navigating IVDR Performance Studies: Key Insights from MDCG 2025-5 Q&A
The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
MedNet EC-REP
Regulatory Updates
MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers
In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.
MedNet EC-REP
Regulatory Updates
MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms
The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms." This document, published in June 2025, clarifies the regulatory obligations for all parties involved in bringing MDSW apps to the EU market, with a particular emphasis on online platform providers. This article provides a concise overview of its key takeaways for regulatory professionals.
MedNet EC-REP