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Showing posts with label EU. Show all posts
Showing posts with label EU. Show all posts

Thursday, October 8, 2026

RED Guide update - 2026

2026 Update to the
"Guide to the Radio Equipment Directive 2014/53/EU"

  • Original Edition: 19 May 2017

  • First Major Revision: 19 December 2018 

  • Latest Comprehensive Revision: 2026 (Updated to provide practical guidance and consensus interpretations following the application of RED Article 3(3)(d), (e), and (f) cybersecurity requirements that became mandatory on 1 August 2025).

  • Supplementary Guidance: RED AdCo published additional cybersecurity guidance on 11 February 2026 to support compliance with the RED cybersecurity Delegated Regulation.

Key updates highlighted in the 2026 RED Guide include:


1. Cybersecurity Realignment (Regulation (EU) 2026/339)

The most significant regulatory development is the alignment of RED cybersecurity provisions with the Cyber Resilience Act (CRA).

• On 16 February 2026, the European Commission adopted Commission Delegated Regulation (EU) 2026/339, repealing Delegated Regulation (EU) 2022/30. [eur-lex.europa.eu]

• The purpose is to prevent overlapping cybersecurity requirements between RED and the CRA. [eur-lex.europa.eu], [webgate.ec.europa.eu]

• The repeal takes effect on 11 December 2027, the date on which the CRA becomes fully applicable. Until 11 December 2027, radio equipment within the scope of Delegated Regulation (EU) 2022/30 must continue to comply with the RED cybersecurity requirements under Article 3(3)(d), (e), and (f). [eur-lex.europa.eu]

2. Update on Reconfigurable Radio Systems

The Commission's earlier work on software-reconfigurable radio systems remains under consideration. Cybersecurity-related aspects originally considered under the initiative have largely been addressed through the CRA framework, helping to avoid duplication between RED and horizontal cybersecurity legislation. 

3. Compliance and Market Surveillance Clarifications

• Where a RED conformity assessment procedure requires third-party involvement, only certificates or opinions issued by a designated RED Notified Body satisfy that requirement. Supporting test reports from other organizations may still form part of the technical documentation. [redca.eu], [single-mar....europa.eu]

• The Common Charger initiative continues to progress under the RED framework, extending USB Type-C charging requirements to additional product categories, including laptops within scope.


REF:
RED Guide (2026)
















Thursday, January 30, 2025

Europe Radio Equipment Cybersecurity update

On January 30, 2025, EN 18031-1, -2 and -3 were listed in the Official Journal of the European Union thus now harmonized to give "presumption of conformity" with the essential requirements set out under articles 3.3 d, e, and f, of the Radio Equipment Directive, however with some conditions and limitations.

These standards where originally released on September 2, 2024.


EN 18031-1:2024 (Common security requirements for radio equipment - Part 1: Internet connected radio equipment)

EN 18031-2:2024 (Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment)

EN 18031-3:2024 (Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value)

It's important to note that these are framework standards defining common security requirements and assessment methods, not test standards.

 REF:

 Commission Delegated Regulation (EU) 2022/30

Document 32025D0138 

 

Wednesday, June 29, 2022

New European Union "Blue Guide" published

 

A new version of the "Blue Guide" on the implementation of EU product rules has been published.

This new version builds on past editions while also reflecting recent changes in EU legislation, in particular, the adoption of new regulations on market surveillance. 

REF:

https://bit.ly/EU-Blue-Guide


Thursday, April 23, 2020

European Union postpones new requirements for medical devices


On Friday, April 17, 2020 The European Parliament has adopted the Commission proposal to postpone the implementation of new approval rules for medical devices,

 

New regulations for medical devices, expected to be fully applicable on May 26, 2020, proposed to be postponed for 1 year (new effective date May 26, 2021).

 

In a press release by the European Parliament they note;

 

“The European Parliament is therefore supporting the proposal to postpone the application of this Regulation by one year to allow authorities and manufacturers alike to prioritise the fight against the coronavirus pandemic by continuing under current procedures.”

 

The European Member States will need to approve the proposal and publish in the Official Journal of the European Union. Expectations are this will happen prior to May 26, 2020.

 

The In Vitro Diagnostics Medical Devices Regulation is not affected by the new proposal, and its applicability date remains, effective May 26, 2022.

 

Ref:

 

EU Parliament press release

 

New regulations on medical devices

Thursday, April 16, 2020

European Union - Internet connected and wearable radio equipment

Update - European Union - Report for the initiative on "internet connected radio equipment and wearable radio equipment" can be found here.