News & Regulatory Updates

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EAR
Regulatory Updates

EU Initiative on Medical Devices and In-Vitro Diagnostics: A Targeted Evaluation

The European Commission has launched a public consultation as part of its targeted evaluation of the EU rules on medical devices and in-vitro diagnostics. This initiative is focused on assessing the effectiveness, efficiency, relevance, and coherence of the current regulations. It aims to ensure that the regulatory framework continues to support innovation, public health, and safety in the rapidly evolving medical technology sector.

MedNet EC-REP
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Brussel EU Parlament
Regulatory Updates

EU Publishes Second Revision of MDCG 2023-3: Key Updates for Manufacturers

The European Commission has released the second revision of the MDCG 2023-3 guidance document in January 2025. This update includes important clarifications in line with Regulation (EU) 2024/1860, affecting the implementation of Eudamed, post-market surveillance, and reporting timelines. Below, we summarize the key changes:

MedNet EC-REP
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EU Parlament
Regulatory Updates

Key Changes in MDCG 2022-4 Rev 2 for Medical Device Manufacturers

The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to the Medical Device Regulation (MDR).

MedNet EC-REP
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MDR
Regulatory Updates

Deadline Alert: Submission Requirements for MDR Conformity Assessment

We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607. As the landscape of medical device regulations continues to evolve, it's crucial for stakeholders to remain informed and compliant.

MedNet EC-REP
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