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Europe & UK (CE & UKCA)

This section details the regulatory requirements and certification strategy for the European Union and the United Kingdom.

European Union (CE Marking)

The EverTag system must comply with the relevant European Directives to bear the CE mark. Because the device contains a radio transmitter, the Radio Equipment Directive (RED) supersedes the standard Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC) Directive.

Radio Equipment Directive (RED) 2014/53/EU

The RED covers all aspects of the product's safety, EMC, and radio spectrum use:

  • Article 3.1(a) Safety & Health: Covers electrical safety (similar to LVD) and human exposure to electromagnetic fields (RF exposure/SAR).
  • Article 3.1(b) EMC: Covers electromagnetic compatibility (similar to EMC Directive).
  • Article 3.2 Radio Spectrum Efficiency: Ensures the radio transmitter uses the spectrum effectively and doesn't cause harmful interference.

(Note: Specific harmonized standards, such as EN 305 550 for 60 GHz Short Range Devices and relevant LTE standards, will be evaluated during Phase 2 of the certification strategy.)

Environmental Directives

  • RoHS (Restriction of Hazardous Substances) 2011/65/EU: Restricts the use of specific hazardous materials found in electrical and electronic products.
  • REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) 1907/2006: Addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.
  • WEEE (Waste Electrical and Electronic Equipment) 2012/19/EU: Sets collection, recycling, and recovery targets for electrical goods. Requires registration in each member state where the product is sold.
  • Battery Directive 2006/66/EC (and new Battery Regulation): Applies if the Connectivity Module includes backup batteries (e.g., PCB 232201, 232203).

United Kingdom (UKCA Marking)

Post-Brexit, the UK requires its own conformity assessment mark (UKCA). Currently, the technical standards required for UKCA marking are identical to the EU's EN standards used for CE marking.

Requirements

  • Technical Standards: The same EN standards used for CE RED compliance are accepted for UKCA.
  • Declaration of Conformity (DoC): A separate UK Declaration of Conformity must be drawn up, referencing the relevant UK statutory instruments instead of EU Directives.
  • Marking: The UKCA mark must be affixed to the product (or packaging/manual, subject to transitional arrangements).

Certification Strategy

  1. Harmonized Standards: We will test against the latest harmonized EN standards published in the Official Journal of the European Union (OJEU) to provide a presumption of conformity with the RED.
  2. Technical Construction File (TCF): We will compile and maintain a comprehensive TCF containing all design documentation, risk assessments, and test reports. This file must be kept for 10 years after the last product is manufactured.
  3. Self-Declaration: For modules where harmonized standards exist and are fully applied, we will follow the internal production control conformity assessment procedure (Module A) and issue a Declaration of Conformity (DoC).
  4. Notified Body: If harmonized standards are not fully applied (e.g., for novel radio technologies or complex co-location scenarios), we will engage a Notified Body for an EU-type examination certificate.