Meet us at MEDICA 2025! 📅 Nov. 17–20 | Hall 3 Booth D43 | Schedule a meeting

MedTec Tokyo 2025

MedNet EC-REP at MedTec Japan 2025 – Meet Us at Booth 3303

MedNet EC-REP GmbH is pleased to announce its participation as an exhibitor at MedTec Japan 2025, one of Asia’s leading trade shows for medical device design and manufacturing. The event will take place in Tokyo from April 9–11, 2025, bringing together industry experts, manufacturers, and regulatory professionals from around the world.

At Booth 3303, our representatives Stefan Selle and Dr. Juliana Jonitz will be available to meet with both existing clients and new medical device manufacturers looking to enter the European market. As a trusted Authorized Representative (EC-REP) and Regulatory Importer, we provide expert guidance on regulatory compliance, ensuring a smooth and successful market entry in the EU.

We look forward to discussing your specific needs and offering tailored solutions to support your business. To schedule a meeting with our team at MedTec Japan, please use our contact form.

See you in Tokyo!

Latest news

Implications of the Update to the Borderline & Classification Manual under MDR and IVDR

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).

Regulatory Affairs Bulletin: Intended Purpose vs Intended Use under MDR & IVDR

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.

MedNet EC-REP GmbH at MEDICA 2025 – Visit Us in Hall 3, Booth D43

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.

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

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).

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).

Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A

Navigating IVDR and MDR 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).

MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers

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.

MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

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."