EU Market Access for Wireless Device

Starting from June 2016 the Radio Equipment Directive (RED) is the new compliance requirement in Europe for wireless transmitters. The RED replaces the R&TTE Directive which previously covered radio transceivers and telephone equipment; both directives can be applied until the end of the transition period on the 12th of June, 2017. As of the 13th of June, 2017, all products regulated by the scope of RED must also meet the RED requirements.

The general requirements for products regulated by the scope of RED are defined as follows:

• protection of the health and safety of humans and household pets and livestock (Article 3.1[a])

• an adequate level of electromagnetic compatibility (Article 3.1[b])

• effective and efficient use of radio spectrum (Article 3.2)

• additional general requirements for categories or classes of radio equipment still to be defined by the European Committee (Article 3.3)

RED applies to all radio equipment being placed on the market. In accordance with RED - «radio equipment» means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as an antenna, so as to intentionally emit/or receive radio waves for the purpose of radio communication and /or radiodetermination.

Equipment not covered by the Directive includes:

• Radio equipment used exclusively for activities concerning public security, defense, state security or for the economic well-being of the state

• Amateur radio equipment

• Marine equipment

• Airborne products, parts and appliances (as regulated under Article 3 of regulation EC 216/2008)

• Custom-built evaluation kits used solely for research and development activities

Thus, it is important to note that:

• All receivers (including broadcast radio and TV equipment) now fall under the scope of RED instead of the EMC Directive.

• The radio frequency spectrum governed within the scope of the Directive now has no lower limit. It has previously been from 9 KHz up to 3000GHz.

• There are no voltage limits for radio equipment regarding LVD safety requirements.

• Manufacturers are solely responsible for conformity assessment, and cannot use the conformity procedures laid out in the LVD or EMC Directive to demonstrate compliance, but must use those outlined in RED instead.

• Radio equipment using special software to enable functions must demonstrate compliance of the equipment together with the software. New versions of software must also prove compliant with the essential requirements.

• Radio equipment capable of taking different configurations must undergo conformity assessment in all possible configurations.

The manufacturer shall perform a conformity assessment of the radio equipment with a view to meeting the essential requirements of RED. Three options are now available for radio equipment manufacturers to prove compliance with the essential requirements. Two of those options involve the participation of a Notified Body:

1. Internal production control (Module A)

The manufacturer undertakes the compilation of the technical documentation (testing can be internal or external), the manufacturing process (involving internal quality control), the CE marking and issuing the Declaration of Conformity. No Notified Body involvement is needed. This option can only be used if harmonized standards have been applied in full for Articles 3.2 and 3.3.

2. EU type examination (Modules B & C)

The manufacturer is responsible for the technical documentation (can be internal or external), the internal production control, the product CE marking and issuing the Declaration of Conformity. The Notified Body will be involved in examining the technical documentation verifying the design, testing and issuing of an EU type examination certificate.

3. Conformity based on full quality assurance (FQA) (Module H)

The manufacturer comes into agreement with a Notified Body for a FQA program. The Notified Body takes part in the auditing of the manufacturing process, the quality system, the product design and testing, as well as taking on surveillance duties of the quality system. The Notified Body also oversees the CE marking and issuing of the Declaration of Conformity. The Notified Body’s numerals appear on the product labelling, only under an FQA agreement with the manufacturer.

Summarise the foregoing:

• RED applies to all electrical or electronic products that intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with such an accessory;

• The radio frequency spectrum now has no lower limit;

• Three options are available for radio equipment manufacturers to prove compliance with the essential requirements (self-declaration if harmonized standards exist for the equipment, otherwise, involvement of Notified Body to ensure compliance of the product);

• In the case of product conformity, the manufacturer affixes CE label and creates a declaration of conformity to be enclosed with the product. 

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