1. An introduction to Directive 2014/53/EU
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An introduction to Directive 2014/53/EU
A new step
Michel Wouters, November 2014

2. Bronvermelding: Directive 2014/53/EU
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Directive 2014/53/EU
2014/53/EU Brussels 13 November 2014
Agentschap Telecom, Informatiesessie RED, 16 Juni.
RTTE-CA Meeting 19 Mei 2014
Contact: Michel Wouters van den Oudenweijer
Managing Director Telefication Certification P:

3. Content of this presentation
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An introduction to the new Radio Equipment Directive (RED) 2014/53/EU
NOTE: only important changes have been highlighted. No rights can be retrieved from this introduction.

4. Scope Important Definition!
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Important Definition!
Radio equipment means an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radio determination, 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 or radio determination.
NOTE: Broadcast/Sound receivers do fall under the RED! Equipment below 9kHz.

5. Scope
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The directive establishes a regulatory framework for making available on the market and putting into service in the Union of RADIO COMMUNICATION equipment ONLY.
Does not apply to:
Equipment emitting radio waves only. (e.g. microwave)
radio equipement for public safety, defence, State security etc. etc.
Leased Line communication Equipment.
Radio Kits used by radio amateurs.
Marine Equipment falling within scope 96/98/EC.
Airborne products, parts and appliances falling within scope article 3 of EC 216/2008.
Custom-built evaluation kits destinated for professionals used for research and development facilities.

6. Essential requirements (1 of 3)
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3.1(a) Protection of health and safety of persons and of domestic animals. (2014/35/EU, no voltage limit)
3.1(b) adequate level of electromagnetic compatibility (2014/30/EU).
3.2 Radio equipment shall be so construed that it both effectively uses and supports the efficient use of radio spectrum to avoid harmful interference.

7. Essential requirements (2 of 3)
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The European commission will appoint the following essential requirements to certain products during the upcoming years. Until today no essential requirement in article 3.3 has been appointed!
3.3 certain categories or classes should also comply with.
(a) Interworking with accessories, inparticular common chargers.
(b) Interworks via networks with other radio equipment.
(c) Connected to interfaces of the appropriate type throughout union.
(d) No harm to the network.

8. Essential requirements (3 of 3)
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(e) Safeguards to ensure protection of personal data and privacy.
(f) protection from fraud
(g) ensuring access to emergency services.
(h) supporting certain features to facilitate by disabled users.
(i) radio equipment supporting certain features in order to ensure that software only can be loaded into radio equipment where the compliance of the combination of radio equipment and software is demonstrated.

9. Administrative requirements (1 of 2)
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Administrative requirements for conformity assessment:
Technical Documentation, CE marking on device, DoC, Notified Body docs (When applicable)
Article 4: Manufacturers of RE and SW allowing radio equipment to be used as intended shall provide the member state and the commission with information on the compliance of the combination. (3i)
Article 5: from June 12th 2018 manufacturers shall register radio equipment types affected by a LOW LEVEL of COMPLIANCE. (Still uncertain)

10. Administrative requirements (2 of 2)
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Administrative requirements dissapear.:
Article 6.4 Notification. (In case non-harmonized frequency)
Alert sign disappears. However in case of restriction on putting into service or of requirements for Authorisation for use, information available on the packaging shall allow the identification of the Member State of the geographical area within a Member State where restriction putting into service of requirements for authorisation of use exist.
CE logo on Manual is not applicable anymore.
Notification networkinterfaces art 4.2 and 7 move to 2008/63/EC

11. Conformity Assessment (1 of 3)
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Equipment where the use of its spectrum allocation is not allowed in at least 1 Member State of Europe, you are not allowed to make the product available on the EU market.
Do NOTE, Not complying to this rule, means NO CE mark may be placed on the device as it does not comply to the Directive. (European commission decission) NO NO
MEANS

12. Conformity Assessment (2 of 3)
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There are 3 assessment procedures:
Internal production control set out in Annex II (DOC harmonised standards in case for Essential Req. 3.1, 3.2 and 3.3.)
EU type examination by NB that is followed by conformity to type based on internal production control Annex III. (EC type examination). Procedure can be followed when compliance to Harmonized and NON-harmonized standards.
Full quality assurance Annex IV. (Placing of NB number after CE Logo.)

13. Conformity Assessment (3 of 3)
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Essential Requirements
Use of harmonized standards
Use of non-harmonized standards
3.1.a protection health, safety
3.1.b EMC
3.2. Efficient use of radio Spectrum
3.3.a,b,c Interworking(accessories, networks, interfaces)
3.3.d No harm to network
3.3.e Safeguarding personal data and privacy.
3.3.f Protection from fraud.
3.3.g Access to emergency services
3.3.h Facilitate users disability
3.3.i. Only Compliant software can be loaded.
NB not mandatory
NB not mandatory
NB mandatory*3

14. Obligations of Economic Operators
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Manufacturer
Authorised
Importer
Distributor
Design and manufacturs conform essential requirements
YES
Placing on the market only when comply to essential requirements
Operate in at least 1 member state
Check
Technical Documentation
Yes +10 years filling
Yes +10 years filling+providing
10 years filling
DOC
Issue
10 years fillng and providing
CE mark
Affix
Type, serial number, id
On equipment (or add)
Name/tradename, postal address
On equipment, packaging.
Check details + add postal importer.
Check details manuf. + importer
Manual + spectrum info and user restrictions.
Issue + add to equipment.
Corrective actions Non compliances
Corrective measures
Inform National authorities when risk.
Yes+ manufacturer
Cooperation National authorities
Cooperation National Authorities for market surveillance
YES + 10year

15. Obligation as Manufacturer
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You will be seen as a manufacturer when you place products under your own name, brandname or change the equipment.

16. Principles CE Marking
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On account of nature of the radio equipment, the height of the CE marking afficed to the radio equipment may be lower than 5mm, provided it remains visible and legible.
The CE marking shall be affixed on the Packaging.
When conformity assessment route as set out in ANNEX IV (full quality assurance) has been followed, ONLY THEN the NB number should be place after the CE mark in SAME HEIGHT.

17. Principles of Declaration of Conformity (1 of 2)
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The DOC should mention the points as identified in ANNEX VI.
Where applicable, description of accessories and components, incl. software, which allow the radio equipment to operate as intended and covered by the EU DOC.
Article 18 mentions that more directives can be mentioned on 1 DOC.
May be placed on internet when reference to product is available. Simplified EU declaration of conformity should always be added to product.

18. Principles of Declaration of Conformity (2 of 2)
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So what should be the content of the DOC!
Radio Equipment (product, type, batch, serial)
Name, address of manufacturer or is authorised rep.
Declaration conformity is issued under sole responsibillity of manufacturer.
Object of declaration (for tracabillity).
Is in conformity with 2014/53/EU (you should not mention LVD/EMC).
Description accessories and components.
Reference to the harmonised standards.
Where applicable NB number and issued EC type certificate number.
Signing, date, place of issue.

19. Principles Technical Documentation (1 of 2)
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As mentioned in Annex V, the TCF should contain:
Showing compliance to the essential requirements in article 3.
General description of radio equipment: (photographs (external, internal, marking), Software versions, user information and installation instructions (Including frequency and power transmitted).
Conceptual design and manufacturing drawings and schemes of compenents, sub assemblies, circuits and other relevant similar elements.
Descriptions and explanations necessary for the understaning of drawings and schemes.

20. Principles Technical Documentation (2 of 2)
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List of harmonised standards applied in full or in part.
Copy of EU DoC.
Where Conformity assessment module in ANNEX III has been applied, copy of the EU-type examination certificate.
Result of design calculations, examitations carried out.
Test reports
Explanation to article 10(2) (At least 1 country operational) and 10(10) information on restrictions.

21. Principles Market Surveillance
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Surveillances increase in every MS. Should a product NOT comply to the requirements as stated in the directive, the surveillance authority will state appropriate corrective actions.
In case the economic operator will not take adequate corrective actions whithin the period referred to as mentioned by the surveillance authority as mentioned in paragraph 1 of article 40. The market surveillance authority is entitled to take all appropriate provissional measures to prohibit or restrict the radio equipment being made available on their national market, to withdraw the radio equipment from that market OR recall it.
This is a change with the R&TTE and a major issue. Please do check this. Market surveillance authorities are more soon authorised to withdraw products from the market.

22. Transitional provisions (1 of 4)
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DO NOTE THE FOLLOWING IMPORTANT MESSAGE!!
THE RED 2014/53/EU CAN NOT BE IMPLEMENTED OR USED BEFORE JUNE 13th UNTIL THAT DATE THE R&TTE NEEDS TO BE USED.
THE NEW EMC DIRECTIVE 2014/30/EU NOT BEFORE APRIL 20th 2016.
NOTE: Receivers should use as from April 20th for 2 months the 2014/30/EU. After June 13th the new RED!

23. Transitional provisions (2 of 4)
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Why!!
The RED needs to be implemented in EACH memberstate firstly.
No Notified Body has been assigned before completion of 1.
Law needs to be implemented at same time by complete Union to show harmonisation.

24. Transitional provisions (3 of 4)
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Can we follow RED before?
No, this can not!
Every GOOD Notified Body is aware and participate in the network. E.g. R&TTE CA or RED CA. They are up to date to the latest regulations.
Products Making available to EU market as from JUNE 13th 2016 can have mentioned RED compliance in DOC etc.!

25. Transitional provisions (4 of 4)
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When follow RED finally?
R&TTE 99/5/EC can not be applied to for products making available to the EU market AFTER June 12th 2017.
RED 2014/53EU needs to be followed on products making available on the EU market as from JUNE 13th 2017.

26. So why we go to the Notified Body under RED?
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ADCO has shown a major issue of non-compliance. Market surveillance authorities will act. You react!
Your succes is quality. Diversify and show you have everyhting alligned.
CE-type examination = Certification!
Market diversification. We European want quality and pay for quality. This is what we like! We do not like rubbish!
You have questions, we LOVE to answer.

27. Questions? Contact: Michel Wouters van den Oudenweijer
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Questions?
Contact: Michel Wouters van den Oudenweijer
Managing Director Telefication Certification P:

28. About Telefication NB R&TTE NB EMC NB MED NB PPE TCB FCC CAB Japan
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NB R&TTE
NB EMC
NB MED
NB PPE
TCB FCC
CAB Japan
CAB Canada

29. About Telefication
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0560
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