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In order to CE Mark and place any radio equipment on the market in EU you need to demonstrate compliance with the Radio Equipment Directive (RED). CE marking is a mandatory conformance mark on products placed on the European market. A CE mark indicates that the manufacturer or its authorized EU representative has declared that the product or equipment complies with all applicable European Directives, and enables the free movements of product within the European market. The CE marking is a declaration by the manufacturer, importer, or the entity first placing the product on the market that the product conforms to the appropriate directives. This is confirmed by the legally binding signature on the Declaration of Conformity.
For Short Range Devices operating in the 2.4 GHz ISM band the relevant Harmonized Standards are:
Bluetooth Low Energy does not classify as FHSS under ETSI specification and instead classifies as other type of wideband modulation (see section 4.2.1 of the EN 300 328 specification). Relevant test requirements for Bluetooth Low Energy are defined in Section 4.3.2. Note that revision 1.9.1 of the test specification introduced a few new tests such as Medium Utilization factor and Duty Cycle, TX-Sequence and TX-Gap. These tests only applies to equipment with higher output power than 10 dBm. Bluetooth Low Energy devices are limited to 10 dBm output power in the EU due to the Power Spectral Density requirement (4.3.2.3), which limits the radiated PSD to 10 dBm/MHz. As such, all required testing for CE/RED can be performed with continuous (static) RF output such as for FCC testing.
EN 300 328 v. 2.1.1, which was released in November 2016, introduced receiver categories, and a receiver blocking test. More details about this and how to perform this test, can be found in this application report: ETSI EN 300 328 RX Blocking Test for Bluetooth Low Energy [23].
There are several routes to demonstrate compliance with the Radio Equipment Directive; for most cases, meeting with the requirements of the relevant Harmonized Standards provides presumption of conformity required, thus enabling you to sign a Declaration of Conformity with confidence. A certified test house will provide the necessary guidance and help required to place your radio product on the market.