EU Commission Updates Guidance on SARS-CoV-2 Test Classification

The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2. The panel notes that, while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.

MedNet EC-REP

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10. Februar 2025

This updated assessment may influence the classification of SARS-CoV-2 tests under Regulation (EU) 2017/746. Manufacturers are encouraged to:

Evaluate how this advice impacts their devices.
Consult with their notified bodies to determine necessary conformity assessment steps if a change in risk class is warranted.

In the interim, devices can continue to be marketed under their current risk classification, provided they meet all necessary requirements for that class, such as batch testing in accordance with Article 100(2)(b) of Regulation (EU) 2017/746.

The Medical Device Coordination Group (MDCG) is updating its guidance on IVD classification (MDCG 2020-16) to reflect this new advice. It's important to note that both the expert panel's advice and the MDCG classification guidance are not legally binding. Manufacturers should determine each device's risk classification on a case-by-case basis, considering the device’s intended purpose and target population. Additionally, the panel's advice pertains to the current epidemiological context, and manufacturers should consider any changes in this context when evaluating the classification of their tests.

For detailed information, please refer to the official announcement: https://health.ec.europa.eu

MedNet EC-REP GmbH remains committed to keeping our clients informed about regulatory updates that may impact their products. We encourage manufacturers to review this new guidance and assess its implications for their devices.

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

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MedNet EC-REP15. Juni 2026

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-REP18. Mai 2026

EU Commission Updates Guidance on SARS-CoV-2 Test Classification

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