Radio Equipment Directive
Table of Contents
- The Directive: RED 2014/53/EU
- Path to EU Market Entry
- Authorized Representatives
- Post-Market Surveillance
- Risks of Non-Compliance
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.
‘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’.
- 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;
The new Directive 2014/53/EU
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
Path to EU Market Entry: Compliance
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 RED Directive, two sorts of essential requirements are defined:
a) 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
b) 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.
At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:
- Keeping the Declaration of Conformity and the technical documentation available to the Competent Authorities at all times and for 10 years after the equipment is placed on the market
- Accommodate any reasoned requests from the Competent Authorities relating the documentation or conformity of the pressure equipment
- Cooperate with the Competent Authorities regarding and actions to be taken to eliminate and risks relate to the pressure equipment for which they are responsible under the mandate
The Authorized Representative should be clearly identified on the packaging to ensure efficient communication from end-users and EU economic operators in regards to the product(s) compliance.
The authorized representative may not draw up technical documentation as referred to in Article 6(2).
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
It is the responsibility of each brand owner 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 comply 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.
Risks of Non-Compliance
Evidently, non-compliant products enter the EU Market everyday - whether the brand owner knowingly does so or due to a lack of knowledge imparted from EU importers/distributors.
As there is no "approval" in the EU Market, Competent Authorities focus almost exclusively 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.
Should you choose to take the risk to ship product to Europe which has not followed the required path to compliance as detailed above, you should also be prepared for the consequences.
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
Ultimately, the prescribed actions that are to be taken in the case that a product is found to be non-compliant will vary depending on the EU Competent Authority which identified the breach, the EU Member State, cooperation from the brand owner and the actions taken by the appointed Authorized Representative. Above all else, the professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling such situations play a vital role in the successful recovery of your brand in the EU Market.
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