News & Regulatory Updates

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30 Articles
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.

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eIFU
Regulatory Updates

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). 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.

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MDSW
Regulatory Updates

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." This document, published in June 2025, clarifies the regulatory obligations for all parties involved in bringing MDSW apps to the EU market, with a particular emphasis on online platform providers. This article provides a concise overview of its key takeaways for regulatory professionals.

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MIR Form
Regulatory Updates

New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

The European Commission has released a new version of the Manufacturer Incident Report (MIR) form-MIR 7.3.1-which will become mandatory for all medical device and IVD manufacturers from November 2025. This update is a significant step in harmonizing and streamlining incident reporting processes across the European Union, in line with the MDR and IVDR requirements.

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EU Flag
Regulatory Updates

EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment

The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the Medical Device Regulation (MDR, EU 2017/745). The latest update, formalised through Commission Implementing Decision (EU) 2025/681, introduces new harmonised standards covering medical gloves for single use, sterilisation of medical devices, and patient handling equipment in ambulances.

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European Parlament
Regulatory Updates

New Revision of MDCG 2020-16 Guidance on IVD Classification: Key Updates in Version 4

The Medical Device Coordination Group (MDCG) published Revision 4 of its guidance document MDCG 2020-16, titled "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746". This updated version provides further clarification on the application of the classification rules outlined in Annex VIII of the IVDR.

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London Eye
Regulatory Updates

UK Updates Post-Market Surveillance Requirements for Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain. The document, titled "The Medical Devices Post-Market Surveillance Requirements (Amendment) Great Britain Regulations 2024: Guidance on Implementation," provides clarification and details on fulfilling the regulatory obligations for manufacturers.

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