News & Regulatory Updates

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29 Articles
create an image that fits to this article teaser: EU Regulation 2026/977: What Medical Device Manufacturers Need to Know About New Notified Body Rules The European Commission has adopted Commission Implementing Regulation (EU) 2026/977, introducing binding uniform rules on how notified bodies must handle quotations, conformity assessment timelines, and re-certification. For manufacturers of medical devices and in vitro diagnostic (IVD) medical devices, this regulation brings long-awaited predictability - and specific new compliance obligations.
Regulatory Updates

EU Regulation 2026/977: What Medical Device Manufacturers Need to Know About New Notified Body Rules

The European Commission has adopted Commission Implementing Regulation (EU) 2026/977, introducing binding uniform rules on how notified bodies must handle quotations, conformity assessment timelines, and re-certification. For manufacturers of medical devices and in vitro diagnostic (IVD) medical devices, this regulation brings long-awaited predictability - and specific new compliance obligations.

MedNet EC-REP
MDRIVDREU-REP+1 more
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MedNet at CMEF Shanghai 2026 | Meet Us There
Company News

MedNet at CMEF Shanghai 2026 | Meet Us There

MedNet EC-REP GmbH will be exhibiting at CMEF Shanghai 2026. Meet our regulatory experts and discover how we support your EU market entry.

MedNet EC-REP
CMEF ShanghaiEU Authorized RepresentativeMDR+2 more
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WHX Dubai 2026
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
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Intended Purpose vs Intended Use
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
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Update to the Borderline & Classification Manual
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
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