A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
EU Legislation on Radio Equipment
Until the publication of the Radio Equipment Directive 2014/53/EU on April 16, 2014 and the subsequent 2 year transition period, the Radio Equipment & Telecommunications Terminal Equipment Directive 1999/5/EC was the reigning legal framework for radio equipment products. From June 13, 2016, the Radio Equipment Directive 2014/53/EU became fully applicable in the EU as the main legal framework for radio equipment products.
Any product placed and made available on the EU Market (either through e-commerce or brick-and-mortar) must comply with the Radio Equipment Directive. Non-EU manufacturers wishing to make their products available to EU citizens must appoint a European Authorized Representative. Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the products.
FAQ: What is Radio Equipment?
Radio equipment is defined as 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 antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination.
FAQ: What is a Manufacturer?
A manufacturer is any natural or legal person who manufactures radio equipment or has radio equipment designed or manufactured, and markets that equipment under his name or trade mark.
The Directive 2014/53/EU (Radio Equipment Directive) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating the making available on the market of radio equipment is entered into force on the 13th of June 2016 replacing the former R&TTE Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment with a transition period of 1 year from the date of adoption.
The New Radio Equipment Directive (RED Directive) requires equipment to be constructed for efficient use of the radio spectrum so as to avoid harmful interference with terrestrial and orbital communications. Therefore, the RED Directive lays down the essential requirements to ensure a high level of protection of public interest.
- Chapter 1: General Provisions- Article 1-9
- Chapter 2: Obligation of economic operators- Article 10-15
- Chapter 3: Conformity of radio equipment – Article 16- 21
- Chapter 4: Notification of conformity assessment bodies – Article 22-38
- Chapter 5: Union market surveillance, control of radio equipment entering the union market and union safeguard procedure – Article 39-43
- Chapter 6: Delegated acts and implementing acts and the committee – Article 44-45
- Chapter 7: Final and transitional provisions – Article 46-52
- Annex I: Equipment not covered by this directive
- Annex II: Conformity assessment module A
- Annex III: Conformity assessment modules B and C
- Annex IV: Conformity assessment module H
- Annex V: Contents of technical documentation
- Annex VI: EU declaration of conformity
- Annex VII: Simplified EU declaration of conformity
- Annex VIII: Correlation table
All equipment using the radio spectrum to communicate falls within the scope of the RED Directive. The RED Directive applies to all radio equipment being placed on the market in the EU with the exception of:
- Radio equipment used exclusively for activities concerning public security, defense, state security or for the economic well-being of the state
- Amateur radio kits
- Marine equipment
- Airborne products, parts and appliances (as regulated under Article 3 of regulation EC 216/2008)
- Custom built kits used solely for research and development activities
With the aim to be in line with the current state of art in the radio-using equipment, the new directive:
- Introduces a broader concept of “radio equipment”. This reasoning is deemed to be behind the removal of the telecommunication term along with apparatus from the directive. (See definition in FAQ above.)
- Removes voltage limits for radio equipment regarding LVD safety requirements;
- Includes on the scope all receivers (including broadcast radio and TV equipment) which previously felt under the scope of the EMC Directive;
- Foresees the possibility for a certain type of products to have a common charging interface.
Conformity assessment procedure
- Module A – INTERNAL PRODUCTION CONTROL ( Annex II)
- Module B and C – EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL ( Annex III)
- Module H – CONFORMITY BASED ON FULL QUALITY ASSURANCE ( Annex IV)
When the Harmonized standards are not applied in full the manufacture must follow the conformity assessment route set out in the Annex III or Annex IV.
In case of radio equipment affected by a low levels of compliance, a prior registration of radio equipment within specific categories is foreseen as measure to improve the market surveillance. By means of implementing acts the Commission will identify the categories of products that require registration and which documentation must be created in relation to them. It is anticipated that the central registry will be made available by the Commission from June 12, 2018 onward.
In the Radio Equipment Directive, two sorts of essential requirements are defined:
- Essential requirements applicable to all radio equipment such as:
- Those covering all health and safety risks arising from the use of equipment, e.g. electrical, mechanical and chemical as well as (but not exclusively) health aspects relating to noise, vibration and ergonomic aspects as set out in the Directive 2014/34/EU.
- Those requirements assuring an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU.
- Those requirements assuring an efficient use of radio spectrum in order to avoid harmful interference as set out in the recital of the Directive 2014/53/2014
- Essential requirements applicable only to certain types of radio equipment pursuant to specific legal acts adopted by the Commission (delegated acts)
The manufacturer puts together the technical documentation which makes it possible to assess whether the radio equipment complies with the requirements of the directive. It contains at least the elements set out in the Annex V.
Non-compliant products enter the EU Market everyday – whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.
Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market. In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:
- Being publicly reported to the RAPEX,
- Warehousing Fees,
- Requested Withdrawal,
- Mandated Withdrawal,
- Product Recall (from end-users and/or the market),
- Complete ban on marketing of the product,
- Destruction of the product,
- Revocation of the CE Marking.
The professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
- Staying up-to-date on new requirements or legislative changes,
- Continual updating of the technical file as modifications are made to the product,
- Reporting of any incidents related to the product use,
- Removal of non-compliant batches from EU economics operators and end-user,
- Keeping technical file available for 10 years after the last batch entered the EU market.
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.