RED (CE) Certification

The Radio Equipment Directive (RED — 2014/53/EU) covers all equipment that emits or receives radio waves. It is a comprehensive directive: it gathers safety (corresponding to LVD's requirements), electromagnetic compatibility and effective use of the radio spectrum under one roof. With the delegated regulation that entered into force in 2022, additional essential requirements on cybersecurity, personal-data protection and fraud prevention (article 3.3 d, e, f) also apply.

• Manufacturers of devices with a Wi-Fi, Bluetooth, NFC or RFID module
• Manufacturers of cellular-connected (2G/4G/5G) products and IoT devices
• Manufacturers of remote controls, radios and alarm systems
• Manufacturers of wireless charging, radar and telemetry equipment
• Those importing these products into the EU

Mandatory for radio equipment. The conformity-assessment route depends on whether the harmonised standards are fully applied: when they are, the manufacturer can self-declare through internal production control (Module A); when they are not, or only partly applied, notified-body involvement (Module B+C or Module H) becomes mandatory. This distinction matters especially for new frequency bands and technologies with no standard.

• Article 3.1(a) — Health and safety: requirements corresponding to LVD, applied without a voltage limit, and EMF exposure (SAR)
• Article 3.1(b) — Electromagnetic compatibility: emission and immunity
• Article 3.2 — Effective use of the radio spectrum: frequency, power, bandwidth, channel spacing, unwanted emissions outside the allocated bands
• Article 3.3(d) — Not harming the network or misusing network resources
• Article 3.3(e) — Protection of personal data and privacy
• Article 3.3(f) — Protection against fraud
• Presenting frequency-band and power information to the user, and the restriction-of-use marking
• Conformity-assessment modules: A, B+C, H
• The technical file, the EU Declaration of Conformity, and marking on the product

1. 1Determining the LegislationIt is determined which EU legislation applies to the product. A product can fall within scope of more than one piece of legislation at the same time; all of them must be met.
2. 2Selecting the Conformity Assessment ModuleThe legislation determines the module to follow according to the product's risk class. The manufacturer self-declares under some modules, while a notified body is involved under others.
3. 3Testing Against Harmonised StandardsConformity with harmonised standards published in the EU Official Journal is demonstrated through testing; this provides a presumption of conformity with the legislation.
4. 4Risk Analysis and the Technical FileThe risk assessment, design calculations, test reports, instructions for use and sample labels are compiled in the technical file.
5. 5The EU Declaration of ConformityThe manufacturer or its EU-based authorised representative signs the declaration of conformity. Responsibility rests with the signatory of the declaration.
6. 6Affixing the CE MarkThe mark is affixed to the product in the form and size the legislation prescribes; the notified body's identification number is added if one is involved.
7. 7Retaining the Technical FileThe technical file is retained for the period the legislation sets from the product's placing on the market (10 years under most legislation) and presented to the competent authority on request.

The CE mark is not a certificate but the manufacturer's declaration of conformity, and it has no expiry. However, the declaration remains valid as long as the product and the legislation do not change: the technical file must be updated if the legislation or the harmonised standard is updated. Notified-body certificates (e.g. an EU Type-Examination Certificate) are subject to a validity period.

• The product description, model list and technical drawings
• Risk assessment
• The list of harmonised standards applied
• Test reports
• Instructions for use and warning labels (in the target market's language)
• A draft EU Declaration of Conformity
• Radio-module information: frequency band, output power, modulation, antenna gain
• Antenna placement and the block diagram
• Radio (spectrum) test report — e.g. EN 300 328, EN 301 511, the EN 301 908 series
• EMC test report — e.g. the EN 301 489 series
• Safety test report — e.g. EN IEC 62368-1
• SAR or EMF exposure assessment report — e.g. EN 62479, EN 50566
• Assessment against the cybersecurity requirements (if article 3.3 d/e/f applies)

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The number of pieces of legislation applicable to the product
• The conformity-assessment module — whether a notified body is involved
• The required test scope and number of samples
• The current state of the technical file
• Translation and documentation needs

A Notified Body under CE is registered in the European Commission's NANDO database for the relevant EU regulation and carries a four-digit identification number. Notified body authority is based on legislation and product scope; The authority granted for one regulation does not extend to another. Testing is within the scope of ISO/IEC 17025, product certification is within the scope of ISO/IEC 17065.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

• CEMachinery Safety
• CELVD
• CEEMC
• CEMDR
• CEIVDR
• CEPED
• CESPVD
• CEATEX