News & Regulatory Updates

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32 Articles

Amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union.

Regulatory Updates

EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers

In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.

MedNet EC-REP

18. Juni 2026

EU-REPEC-REPMDR+1 more

Regulatory Updates

New swissdamed registration fees - what manufacturers need to know from 2027

From 1 July 2026, all medical devices placed on the Swiss market must be registered in the national swissdamed database. Together with this registration obligation, the Swiss Federal Council has approved a revised Swissmedic fee ordinance introducing a product registration fee. The first invoices will be issued in January 2027. Here is what to expect.

MedNet EC-REP

15. Juni 2026

MedDOIvDOSwissdamed+1 more

erstelle ein bild auf dem keine personen abgebildet werden. Das bild muss zu diesem Artikel passen: eIFUs – How to benefit as professional-use device manufacturer?
EU Expands eIFU Eligibility for Professional-Use Devices under Commission Implementing Regulation (EU) 2025/1234
The regulatory framework for electronic Instructions for Use (eIFU) in the European medical device sector continues to evolve. With the adoption of Commission Implementing Regulation (EU) 2025/1234, the European Commission has expanded the categories of medical devices that may provide instructions for use in electronic form (https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj/eng).
For manufacturers of medical devices and in-vitro diagnostics (IVDs), this amendment to Commission Implementing Regulation (EU) 2021/2226 represents an important step toward digital product documentation, while maintaining the safety principles established under the Medical Device Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.
eIFU Remain Limited to Professional-Use Devices
A key regulatory principle remains unchanged: electronic instructions for use may only replace paper instructions for devices intended exclusively for professional users.
Devices intended for lay users, home-use diagnostics, or consumer healthcare applications must continue to include paper instructions for use. Manufacturers must therefore carefully evaluate the intended user group and foreseeable use scenarios during regulatory classification and risk management.
Regulatory Requirements under MDR and IVDR
Both MDR and IVDR define general obligations regarding the information supplied with medical devices and IVDs.
Key provisions include:
MDR Article 10(11) and Annex I Chapter III, 23
IVDR Article 10(10) and Annex I Chapter III, 20
These sections require manufacturers to ensure that instructions for use are:
clear and understandable
accessible to the intended user
kept up to date throughout the device lifecycle.
In addition, the norm EN ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer is useful as support for the preparation of the instruction for use.
A Key Advantage: Managing EU Language Requirements
One of the most practical advantages of eIFU is the simplified management of national language requirements across the EU.
Under MDR and IVDR, instructions for use must be provided in the official language(s) required by each Member State where the device is made available. (See EU overview of language requirements https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en)
For manufacturers distributing devices in multiple EU markets, this often means maintaining a large number of translated IFU versions.
A compliant eIFU platform enables manufacturers to:
host all required translations in one central location
provide immediate access to the correct language version
update individual translations without reprinting entire manuals.
If all required translations are available electronically, manufacturers can more efficiently meet EU language compliance obligations while avoiding complex logistics related to multilingual printed instructions.
Operational Benefits of eIFU
Beyond language management, eIFU offer several additional advantages for Regulatory Affairs and Quality teams.
Faster safety updates
Electronic IFU allow manufacturers to publish updated instructions immediately after regulatory approval.
Improved document control
Digital platforms support version tracking, traceability, and archived access to previous IFU versions.
Sustainability and logistics efficiency
Reducing printed documentation decreases packaging volume and environmental impact.
Key Compliance Considerations
Despite these benefits, manufacturers must address several regulatory requirements.
Risk Assessment
The manufacturer must perform a documented risk assessment to show that providing IFUs electronically maintains or improves safety compared with paper.
Availability and Access
eIFUs must be available in all EU Member States where the device is placed on the market, unless justified otherwise in the risk assessment.
They must be accessible on a website or electronic medium and provided in a commonly used format that can be read with freely available software.
Website Requirements
Websites used to host eIFUs must meet the following conditions:
Protected against unauthorized access and tampering.
Stable internet address, directly accessible.
Must fulfil data protection requirements (GDPR).
Ensure minimal server downtime and display errors.
Request for Paper Version
Even if IFUs are delivered electronically, manufacturers must have a system to provide a paper version at no extra cost upon user request, normally within 7 calendar days of request.
Labeling
Manufacturers must clearly indicate on the device label or packaging that instructions are supplied electronically and provide information on how to access them.
Retention and Versions
eIFUs must be retained in electronic form for specified periods after the device is last placed on the market:
10 years for devices with a defined expiry date (except implantable).
15 years for implantable devices or devices without a defined expiry date.
Historical versions (including publication dates) must be accessible on the website or, if obsolete, available on request.
Connection to UDI and Eudamed
Once Eudamed’s UDI database registration becomes mandatory, the manufacturer must provide the internet address (URL) where the eIFU is accessible to the database.
Conclusion
The updated EU eIFU framework expands opportunities for digital instructions for use across the medical device sector. However, manufacturers must ensure strict compliance with regulatory conditions—particularly the requirement that eIFU replacing paper instructions are only permitted for devices intended exclusively for professional users.
When implemented correctly, eIFU not only support regulatory compliance under MDR and IVDR but also provide a significant advantage in managing multilingual documentation across the European market.

Regulatory Updates

EU Expands eIFU Eligibility: Key Changes under Implementing Regulation (EU) 2025/1234

The EU expands the use of electronic Instructions for Use (eIFU) for professional-use medical devices under Implementing Regulation (EU) 2025/1234. Key compliance considerations for MDR and IVDR manufacturers.

MedNet EC-REP

18. Mai 2026

MDRIVDReIFU

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

06. Mai 2026

MDRIVDREU-REP+1 more

Guides

10 Essential Tips for Non-EU Cosmetic Manufacturers Entering the EU Market

Planning to sell cosmetics in Europe? Discover the essential compliance requirements and strategic tips that non-EU manufacturers need to successfully enter the EU market.

MedNet EC-REP

03. Apr. 2026

EU cosmetic regulationsmarket entrycompliance+3 more

Guides

Efficient EUDAMED UDI Bulk Uploads - MedNet EC-REP Introduces a Cost-Effective Solution

The European database for medical devices, EUDAMED, is entering a new phase. With several modules now declared fully functional, the use of the system - including the UDI/Device registration module - will soon become mandatory for economic operators under the EU MDR and IVDR.

MedNet EC-REP

10. März 2026

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

09. März 2026

CMEF ShanghaiEU Authorized RepresentativeMDR+2 more

Company News

MedNet EC-REP GmbH Exhibiting at MedTech Japan 2026

MedNet EC-REP is pleased to announce that we will be exhibiting at MedTech Japan 2026, one of Asia’s leading events for medical device innovation.

MedNet EC-REP

02. März 2026

Regulatory Updates

MDCG 2025-10: New PMS Guidance for MDR & IVDR

The MDCG released new PMS guidance in December 2025. Learn what MDCG 2025-10 means for your MDR and IVDR compliance strategy.

MedNet EC-REP

19. Dez. 2025

MDRIVDRPost-Market Surveillance+2 more

Regulatory Updates

EUDAMED’s first four modules become mandatory on 28 May 2026 - what this means for medical device manufacturers

The European Commission (EC) has formally declared that the first four modules of EUDAMED - the European Database on Medical Devices - will become mandatory as of 28 May 2026.

MedNet EC-REP

27. Nov. 2025

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

26. Nov. 2025

Regulatory Updates

MHRA Introduces New Device Registration Fee: What Manufacturers Need to Know

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its “DORS Fees Guidance 2.1”, introducing a new annual fee model for device registration.

MedNet EC-REP

25. Nov. 2025