Meet Us at Arab Health 2025!
We are thrilled to announce that we will be attending Arab Health 2025, taking place from Monday, January 27, 2025, to Thursday, January 30, 2025, in Dubai. This premier healthcare event brings together professionals from across the globe to explore the latest innovations and developments in the medical sector.
We are excited to offer the opportunity for one-on-one meetings with our team members, Stefan Selle and Adina Wagner. They will be available throughout the event to discuss your regulatory needs, from European, UK, and Swiss medical device compliance to market access solutions.
Book Your Appointment
Stefan and Adina are happy to meet with you to discuss how we can assist you with navigating the complexities of medical device regulations and ensure smooth market access. To arrange a meeting, please contact us via email or through our website’s contact form.
We look forward to connecting with you at Arab Health 2025 and helping your business thrive in the global healthcare market!
Latest news
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
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.
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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
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
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
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
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
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."