Anwendungsbereich des Regulatory Essentials
Geltende Rechtsvorschriften:
The applicable harmonization legislation is the so-called Electromagnetic Compatibility Directive (EMCD) 2014/30/EU which is mandatory since 20 April 2016.
Regulation (EU) 2019/1020 on market surveillance and compliance of products
Adds the definition of
- fulfilment service provider
and have some more details if the manufacturer is located outside EU.
IMERA: Regulation (EU) 2024/2747 Internal Market Emergency and Resilience Act
Directive (EU) 2024/2749
Emergency procedures for the conformity assessment, presumption of conformity, adoption of common specifications and market surveillance due to an internal market emergency.
This directive changes the directive 2014/30/EU.
Additional definitions:
(26) “crisis-relevant goods” means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747;
(27) “internal market emergency mode” means internal market emergency mode as defined in Article 3, point (3), of
Regulation (EU) 2024/2747.
Additional Articles: 40a - 40c
In case of an emergency due to war or disease or other items where the supply chain may be interrupted. The authorities, Notified Bodies and surveillance entities shall have measures for the processes of this directive.
Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung: