Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
The European database for medical devices, EUDAMED, is entering a new phase. With several modules now declared fully functional, the use of the system - including the UDI/Device registration module - will soon become mandatory for economic operators under the EU MDR and IVDR.
MedNet EC-REP GmbH will be exhibiting at CMEF Shanghai 2026. Meet our regulatory experts and discover how we support your EU market entry.
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MedNet EC-REP is pleased to announce that we will be exhibiting at MedTech Japan 2026, one of Asia’s leading events for medical device innovation.
The MDCG released new PMS guidance in December 2025. Learn what MDCG 2025-10 means for your MDR and IVDR compliance strategy.
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 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.
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.
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 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.
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.
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.
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.