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RS 734.5 Order of 25 November 2015 on Electromagnetic Compatibility (OCEM)

Original Language Title: RS 734.5 Ordonnance du 25 novembre 2015 sur la compatibilité électromagnétique (OCEM)

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734.5

Electromagnetic Compatibility Order

(OCEM)

November 25, 2015 (State on June 13, 2016)

The Swiss Federal Council,

See art. 3, para. 2, let. D, of the Act of 24 June 1902 on electrical installations 1 , pursuant to the Telecommunications Act of April 30, 1997 (CTA) 2 , pursuant to the Federal Act of 6 October 1995 on Technical Barriers to Trade (LETC) 3 ,

Stops:

Chapter 1 General provisions

Art. 1 Purpose

1 This order applies to equipment capable of causing electromagnetic disturbance or whose operation may be affected by such disturbances.

2 This order deals with:

A.
Supply, provision on the market, commissioning, setting up and use of equipment;
B.
The recognition of testing laboratories and conformity assessment bodies;
C.
Control of equipment.
Art. 2 Definitions

1 The term is:

A.
Equipment: A fixed device or facility;
B.
Appliance:
1.
Any finished device or any combination of such devices made available on the market as an independent functional unit, intended for the end user, capable of causing electromagnetic disturbance or Operation may be affected by such disturbances,
2.
Any component or sub-assembly intended to be incorporated by the end user into such a device and which is likely to cause electromagnetic disturbances or whose operation may be affected by such disturbances,
3.
Any combination of such devices and, where applicable, other devices, intended to be moved and to operate in different locations (mobile installation);
C.
Fixed installation: A particular combination of apparatus and, where applicable, other devices, that are assembled, installed and intended for permanent use at a predefined location;
D.
Electromagnetic disturbance: Any electromagnetic phenomena that may result in the operation of equipment, such as an electromagnetic noise, an unwanted signal, or a modification of the propagation medium itself;
E.
Immunity: The ability of equipment to function as intended, without degradation, in the presence of electromagnetic disturbances;
F.
Offer: Proposing the making available on the market of devices by exhibiting them in commercial premises, by presenting them in exhibitions, in prospectuses, in catalogues, in electronic media or in any other way;
G.
Making available on the market: Any supply of apparatus for distribution, consumption or use in the Swiss market, for consideration or for free;
H.
Placing on the market: The first provision of a device in the Swiss market;
I.
Commissioning: the first implementation and use of equipment;
J.
Set up: Putting equipment in a state of operation;
K.
Manufacturer: Any natural or legal person producing a device or developing or producing a device, and placing the device under its name or mark on the market;
L.
Agent: Any natural or legal person established in Switzerland who has received a written mandate from the manufacturer to act on his behalf for the purpose of carrying out specific tasks;
M.
Importer: Any natural or legal person established in Switzerland who makes the placing on the Swiss market of an apparatus from abroad;
N.
Distributor: Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market;
O.
Economic operators: The manufacturer, agent, importer and distributor;
P.
Mark of conformity: The trade mark by which the manufacturer indicates that the device complies with the applicable provisions of the Swiss legislation providing for its affixing.

2 The importation of appliances destined for the Swiss market is equated with placing on the market.

3 The supply of a device is deemed to be made available on the market.

4 The placing on the market of an imported used apparatus is equivalent to placing a new device on the market, provided that no identical new device has already been placed on the Swiss market.

5 An importer or distributor is considered to be a manufacturer:

A.
When placing a device on the market under its name or mark, or
B.
When amending a device already placed on the market in such a way that compliance with this order may be affected.

6 The repair of equipment is considered to be a use.

Art. 3 Exceptions

This order does not apply to:

A.
Equipment whose electromagnetic compatibility is the subject of specific provisions;
B.
To equipment:
1.
Incapable of producing or contributing to the production of electromagnetic emissions that exceed a level permitting telecommunication facilities and other equipment to operate as intended, and
2.
Functioning without unacceptable degradation in the presence of electromagnetic disturbances normally present during intended use;
C.
To radiocommunication installations within the meaning of s. 2, para. 1, let. A, of the order of 25 November 2015 on telecommunication installations 1 Used by amateur radio operators, unless such facilities are available on the market;
D.
The kits of components intended to be assembled by the amateur radio operators as well as the installations made available on the market and which are modified by and for amateur radio operators;
E.
Custom evaluation kits intended for use by professionals only in research and development facilities for such purposes;
F.
Apparatus used exclusively for the execution by the competent federal bodies of tasks pursuant to the Act of 3 February 1995 on the army 2 , of the Federal Act of 21 March 1997 establishing measures for the maintenance of internal security 3 Or the Federal Act of 3 October 2008 on Civil Intelligence 4 .

1 RS 784.101.2 . New expression according to Art. 43 al. 1 let. D de l' O of 25 nov. 2015 on telecommunications installations, in force since 13 June 2016 ( RO 2016 179 ).
2 RS 510.10
3 RS 120
4 RS 121

Art. 4 Essential requirements

The equipment shall be designed and manufactured in accordance with the prior art, in order to ensure:

A.
That the electromagnetic disturbances produced do not exceed the level beyond which the telecommunication facilities within the meaning of s. 3, let. D, CTA and other equipment may not function as intended;
B.
That they possess a level of immunity to the electromagnetic disturbances expected in the framework of the intended use, which enables them to function without unacceptable degradation of that use.
Art. 5 Technical Standards

1 The Federal Communications Office (OFCOM) designates, in agreement with the State Secretariat for the Economy, the technical standards to meet the essential requirements of this order.

2 As far as possible, it refers to harmonised international standards.

3 It may entrust independent Swiss standardisation bodies with the elaboration of technical standards or the task itself.

4 It publishes the designated technical standards in the Federal Worksheet 1 .


1 The standards can be consulted or obtained against payment from the Swiss Standards Association, Bürglistrasse 29, 8400 Winterthur, www.snv.ch.

Art. 6 Compliance with essential equipment requirements

1 Equipment complying with technical standards, or parts of technical standards, referred to in s. 5, are presumed to meet the essential requirements for their aspects covered by these standards or parts of standards.

2 In the event of a change to a designated technical standard, OFCOM shall indicate at which time the presumption of conformity set out in para. 1 stops for equipment conforming to the previous version.

Art. 7 Testing Laboratories and Conformity Assessment Bodies

1 Testing laboratories and conformity assessment bodies that produce reports or certificates must:

A.
Be accredited in accordance with the order of 17 June 1996 on accreditation and designation 1 ;
B.
Be recognized by Switzerland under international agreements, or
C.
Be entitled to another title by Swiss law.

2 Anyone who relies on documents from an organization other than those referred to in para. 1 must make it likely that the testing or evaluation procedures and the qualifications of the said body comply with the Swiss requirements (Art. 18, para. 2, LETC).


Chapter 2 Provision of new equipment on the market

Section 1 General conditions

Art. 8

Devices may only be made available on the market if they comply with the provisions of this Ordinance as long as they are properly installed and maintained and used in accordance with the intended purpose.

Section 2 Apparatus

Art. Conformity Assessment Procedures

1 The manufacturer must demonstrate the compliance of the devices to the essential requirements of this order by means of one of the following compliance assessment procedures:

A.
Internal manufacturing control (Schedule 2);
B.
Type examination followed by type compliance on the basis of internal manufacturing control (Annex 3).
2 The manufacturer may choose to restrict the application of the procedure referred to in para. 1, let. B, certain aspects of the essential requirements of this order, provided that, in respect of other aspects of the essential requirements, the procedure referred to in para. 1, let. A, be applied.
Art. 10 Technical documentation

1 The manufacturer shall prepare the technical documentation before the device is placed on the market and shall keep it up to date. It must:

A.
Permit the assessment of the device's compliance with the essential requirements of this order, and
B.
Demonstrate compliance of the device to those requirements.

2 The technical documentation shall specify the applicable requirements and shall cover, to the extent necessary for the evaluation, the design, manufacture and operation of the device.

3 Where the manufacturer implements the procedure referred to in s. 9, para. 1, let. B, the technical documentation includes adequate analysis and assessment of the risk (s).

4 The technical documentation shall contain, where appropriate, at least the following:

A.
A general description of the device;
B.
Drawings of design and manufacturing as well as schematics of components, subassemblies, circuits, etc.;
C.
The descriptions and explanations necessary to understand these drawings and diagrams and the operation of the apparatus;
D.
A list of technical standards referred to in s. 5, applied in whole or in part and, where these standards have not been applied, the description of the solutions adopted to meet the essential requirements of this order, including a list of other technical specifications Applied; in the case of partial application of the technical standards referred to in Art. 5, the technical documentation specifies the applied parts;
E.
Results of design calculations, checks carried out, etc.;
F.
Test reports.

4 If the technical documentation is not in one of the official languages of Switzerland or in English, the OFCOM may request a full or partial translation into one of the aforementioned languages.

Art. 11 Declaration of Conformity

1 The declaration of conformity shall be established by the manufacturer or his authorised representative, in accordance with the model set out in Annex 4. It certifies that compliance with the essential requirements has been demonstrated and is continuously updated.

2 It must be written or translated into one of the official languages of Switzerland or English.

3 If the device is subject to several regulations requiring a declaration of conformity, a single declaration must be made. A file consisting of several individual declarations shall be treated as one declaration.

Art. 12 Retention of the declaration of conformity and technical documentation

1 The manufacturer, his authorised representative, or if neither of these two persons is established in Switzerland, the importer, must be able to submit a copy of the declaration of conformity and of the technical documentation for ten years from the day on which the Market.

2 In the event of the placing on the market of sets of devices, the short period from the date of placing on the market of the last device of the series concerned.

Art. 13 Compliance mark, identification and traceability information

1 Each device shall bear the compliance mark set out in Annex 1, c. 1, or the foreign conformity mark referred to in Annex 1, c. 2.

2 The conformity mark shall be displayed in a visible, legible and indelible manner on the device or on its nameplate. Where this is not possible or is not justified in view of the nature of the device, it shall be displayed in a visible and legible manner on the packaging and accompanying documents.

3 Each device must be identified by its type, lot, serial number, or other data for unambiguous identification. Where the size or nature of the device does not permit it, such information shall appear on the package or in a document accompanying the device.

4 Each device must bear the name, name or registered trademark of the manufacturer and the mailing address to which it can be contacted. Where this is not possible, this information must appear on its packaging or in a document accompanying it. The address specifies a unique location where the manufacturer can be contacted. The coordinates are indicated in a language which is easily understood by the end users.

5 If the manufacturer is not established in Switzerland, each device must also bear the name, name or registered trademark of the importer, as well as the mailing address to which it can be contacted. Where this is not possible, such information shall appear on the packaging of the device or in a document accompanying it. The coordinates are indicated in a language which is easily understood by the end users.

Art. 14 Other information

1 Each device shall be accompanied by the following information:

A.
Any specific precautions to be taken when mounting, installing, maintaining or using the device, to ensure that, once used, it meets the essential requirements of this order;
B.
A clear indication of employment restrictions for devices whose compliance with the essential requirements of this order is not ensured in residential areas.

2 Where applicable, the indication provided for in para. 1, let. B, will also be included on the package.

3 The information necessary for the use of the device in accordance with the intended purpose shall be included in the accompanying instructions.

4 The information is written in an understandable way by the end users, in the official language of the place where the installation is offered for sale. In bilingual sites, they must be in both official languages.

Section 3 Apparatus for incorporation into a fixed installation

Art. 15

1 Devices made available on the market and capable of being incorporated into a fixed installation shall be subject to all applicable provisions concerning apparatus contained in this order.

2 Devices intended to be incorporated into a particular fixed installation and which have not been made available on the market otherwise are not subject to s. 4, 8 to 12, 13, para. 1, and 14.

3 Documentation accompanying an apparatus referred to in para. 2 shall contain the following particulars, in addition to those required by s. 10, para. 2 to 4:

A.
The designation of the fixed installation in which it is to be incorporated and the characteristics of the installation in terms of electromagnetic compatibility;
B.
The arrangements to be made at the time of incorporation of the device into the facility to prevent its compliance from being affected.

Section 4 General obligations of economic operators

Art. 16 Identification obligations

1 At the request of OFCOM, economic operators identify:

A.
Any economic operator who provided them with a device;
B.
Any economic operator to whom they provided a device.

2 They must be able to communicate the information referred to in para. 1 for ten years from the date on which the aircraft was supplied to them, on the other hand, from the date on which they supplied the aircraft.

Art. 17 Obligations related to transportation and storage

Importers and distributors must ensure that, as long as a device is under their control, its storage or transportation conditions do not compromise its compliance with the essential requirements of this order.

Art. 18 Follow-up obligations

1 Manufacturers and importers who consider or have reason to assume that a device they have placed on the market does not comply with this order shall immediately take the necessary corrective measures to Compliance or, if necessary, remove or recall it.

2 Distributors who consider or have reason to assume that a device they have made available on the market is not in compliance with this order shall ensure that the necessary corrective measures are taken to place it In compliance or, if necessary, withdraw it or recall it.

3 In addition, if the device poses a risk, manufacturers, importers and distributors must immediately inform the OFCOM, including details of the non-compliance and the corrective measures taken.

Art. 19 Collaborative Obligations

1 Upon a reasoned request by OFCOM, economic operators shall provide it with all the information and documents necessary to demonstrate the conformity of the device with this order.

2 The information and documents must be communicated in writing on paper or electronically, in a language easily understood by OFCOM.

3 At the request of OFCOM, the economic operators shall cooperate in the implementation of any measures designed to eliminate the risks presented by a device which they have made available on the market. This obligation also applies to the agent in respect of the apparatus covered by his mandate.

Chapter 3 Fixed Facilities

Art.

1 Fixed installations shall be installed in accordance with good engineering practices and in accordance with the instructions for the intended use of their components, and shall meet the essential requirements of this order.

2 Good engineering practices must be documented by the person who performed the assembly. These documents are provided to the owner of the fixed facilities.

3 The owner must keep these records for as long as the facility is in service. It shall make them available to OFCOM if it so requests.

Chapter 4 Commissioning and use of equipment

Art.

1 Equipment put into service must comply with this order. They shall be properly installed and maintained and used in accordance with the intended purpose.

2 The commissioning and use of equipment must comply with the manufacturer's instructions.

3 When a service provider puts into service equipment, it must respect good engineering practice.

4 The repair of equipment must meet the essential requirements.

Chapter 5 Exhibition and demonstration of equipment

Art.

1 Any person who exposs or presents equipment that does not meet the requirements for making available on the market or for putting it into service must clearly indicate that the equipment is not in conformity with the requirements and that it cannot Be made available on the market or put into service.

2 A demonstration cannot take place before measures are taken to prevent any risk of electromagnetic disturbance.

Chapter 6 Placing of used equipment on the market

Art.

1 Used equipment can only be made available on the market if it complies with the provisions in force at the time of placing it on the market.

2 Used equipment with modified components that are important to its operation is subject to the same provisions as new equipment.

Chapter 7 Control

Art. 24 Principles

1 OFCOM verifies that the equipment made available on the market, put into service, put in place or used is in conformity with this order.

2 It shall carry out such checks on a sample basis. It also carries out control when it has reason to assume that equipment is not in compliance with this order.

3 It can access the premises where the equipment is located free of charge to ensure that they comply with this order. He may request that devices be provided free of charge.

4 It may request the Federal Customs Administration (AFD) to provide information on imports of devices for a specified period of time.

5 If AFD discovers in its ordinary course of activities that it suspects, on the basis of a list of checks provided by OFCOM, that it does not comply with this order, it shall take a sample which it transmits without Delay to OFCOM.

Art. 25 Skills

1 The OFCOM is entitled to ask the economic operators, the service provider responsible for the commissioning of an equipment or the owner of a facility, to set up the documents and information needed to carry out its tasks. Control. It sets an appropriate deadline for this.

2 As part of the controls, operators and users are required to provide:

A.
Documents relating to the equipment in their possession, and
B.
Information identifying the person responsible for making available on the market, the owner or the operator.

3 If there is reason to suppose that a fixed installation does not comply with the requirements, especially in the event of a disturbance, OFCOM may ask the owner to provide proof that the installation complies with the essential requirements Of this order.

Art. 26 Testing by a laboratory

1 OFCOM tests equipment by a laboratory within the meaning of s. 7:

A.
If the tests it has conducted itself establish that the equipment does not meet the essential requirements, and
B.
If the request is made by the person responsible for making available on the device market or by the owner of the fixed installation.

2 Before testing a device, it hears the person responsible for making it available on the market. Before conducting tests on a fixed installation, it hears the owner of the fixed installation.

3 The cost of testing the laboratory shall be borne by the person responsible for making available on the market of the apparatus or by the owner of the fixed installation if the tests establish that the apparatus or fixed installation does not Does not meet the requirements.

4 OFCOM may conduct tests by a laboratory when it cannot carry out the tests itself. In this case, the person responsible for making available on the market a device that does not meet the essential requirements or the owner of the fixed installation that does not meet those requirements will be charged the same costs as if OFCOM had itself carried out the tests. The s. 2 and 3 are not applicable.

Art. 27 Measures

1 If the control establishes a breach of the provisions of this order, OFCOM shall take the appropriate measures after hearing the person responsible for making available on the market of the device, the operator or the owner of the Equipment.

2 If equipment is found to be disturbing or disturbed, OFCOM may include:

A.
Prohibit any new making available on the market;
B.
Order recall, forfeiture or sequestration;
C.
Prohibit or limit further use, or
D.
Require modification of equipment.

3 It may publish these measures or make them available online.

4 OFCOM can inform the public about the technical non-compliance of a device, especially when it is not possible to identify all economic operators or there are too many of them. To this end, it shall publish or make available online in particular the following information:

A.
Measures taken;
B.
The intended use of the device;
C.
Information enabling identification, such as manufacturer, mark and type;
D.
Photographs of the device and its packaging;
E.
The date of the non-compliance decision.

Chapter 8 Disturbances

Art. 28

1 On request, OFCOM attempts to determine the origin of a disturbance.

2 To determine the origin of a disturbance, OFCOM has free access to all equipment.

3 OFCOM shall decide on the measures to be taken in order to put an end to the disturbance and, where appropriate, the apportionment of the costs entailed by these measures.

Chapter 9 Fees

Art.

1 OFCOM views an emolument:

A.
For the decisions it makes when, in carrying out its supervisory duties, it finds a non-compliance with the provisions of this order;
B.
For costs incurred in the search for the origin of a disturbance, with the operator of the disturbed or disruptive equipment, if the cause of the disturbance lies in the fact that such equipment:
1.
Does not correspond to the current state of the art;
2.
Has not been put into service in accordance with the manufacturer's instructions and good engineering practices, or
3.
Was not used in accordance with employment restrictions (s. 14, para. 1, let. (b).

2 The emoluments are calculated according to the time spent. The rate applied is 210 francs per hour.

3 The fee levied to seek the origin of a disturbance rises to at least 175 francs. The time required to travel to the site is not considered.

4 Moreover, the General Order of 8 September 2004 on emoluments 1 Is applicable.


Chapter 10 Final provisions

Art. Repeal and modification of other acts

1 The order of 18 November 2009 on electromagnetic compatibility 1 Is repealed.

2 And 3 ... 2


1 [ RO 2009 6243 , 2014 4159]
2 The mod. Can be viewed at RO 2016 119 .

Art. Entry into force

This Order comes into force on April 20, 2016.

Annex 1

(art. 13, para. 1)

Compliance mark

1. Swiss mark of conformity

1.1.
The Swiss conformity mark consists of the two large Latin letters "C" and "H" braces: "CH". The letters must be applied in an elliptical shape, the main axis of the ellipse being horizontal.

Image

Minimum dimensions:

Height of the ellipse

Width of the ellipse

Letter Height

Letter Width

Line Thickness

7.2 mm

11 mm

5 mm

2.5 mm

0.6 mm

1.2.
In the event of a magnification of the conformity mark, the proportion of the conformity mark must be respected.

2. Foreign Compliance Mark

2.1.
The mark of conformity as defined in Annex II to Regulation (EC) No O 765/2008 1 The illustration is informative.

Image

2.2.
The affixing of this mark of conformity must comply with the general principles laid down in Art. 30 of the Regulation (EC) n O 765/2008.

1 Regulation (EC) n O 765/2008 of the European Parliament and of the Council of 9 July 2008 laying down the requirements for accreditation and market surveillance for the marketing of products and repealing Regulation (EEC) No O 339/93 of the Council, OJ L 218, 13.08.2008, p. 30.


Status June 13, 2016

Annex 2

(art. 9, para. 1, let. (a)

Internal manufacturing control (module A)

1.
The internal control of manufacturing is the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in the c. 2, 3, 4 and 5 of this Annex, and shall ensure and declare under its sole responsibility that the devices concerned satisfy the requirements of this order which are applicable to them.
2.
Electromagnetic compatibility assessment
2.1
The manufacturer shall carry out an assessment of the electromagnetic compatibility of the devices, on the basis of the phenomena to be taken into account, with a view to satisfying the essential requirements of this order.
2.2
The assessment of electromagnetic compatibility shall take into account all normal operating conditions. In cases where devices can take several configurations, the electromagnetic compatibility assessment shall determine whether they meet the essential requirements of this order in all possible configurations. Identified by the manufacturer as representative of the intended use.
3.
Technical documentation
The manufacturer shall draw up the technical documentation referred to in Art. 10.
4.
Manufacturing
4.1
The manufacturer shall take all necessary measures to ensure that the manufacturing process and its follow-up ensure the conformity of the devices manufactured to the technical documentation referred to in Art. 10 and the essential requirements of this order.
4.2
The manufacturer shall take due account of changes in the design or characteristics of the device as well as modifications of the harmonised standards or other technical specifications to which the conformity of the device is Declared.
5.
Compliance mark and declaration of conformity
5.1
The manufacturer shall affix the mark of conformity on each device that meets the applicable requirements set out in this order.
5.2
The manufacturer shall establish, in writing, a declaration of conformity for each device model.
6.
Agent
6.1
The manufacturer's obligations under c. 5 may be completed by its agent, on its behalf and under its responsibility, provided that they are specified in the terms of reference.
6.2
The design and manufacture of equipment and the establishment of technical documentation cannot be delegated to the agent.

Status June 13, 2016

Annex 3

(art. 9, para. 1, let. (b)

Type examination followed by type compliance on the basis of internal manufacturing control

I Type Examination (Module B)

1.
The type examination is the part of the conformity assessment procedure by which a conformity assessment body reviews the technical design of a device and verifies and certifies that it meets the essential requirements of the This order.
2.
The type examination shall consist of an assessment of the adequacy of the technical design of the device by a review of the technical documentation referred to in c. 3, without examination of a sample (design type). It may be limited to certain aspects of the essential requirements of this order as indicated by the manufacturer or his agent.
3.
Request for type examination
3.1
The manufacturer shall submit a request for a type examination to a single conformity assessment body of its choice.
3.2
The application shall specify the aspects of the essential requirements for which the examination is requested and shall include:
(a)
The name and address of the manufacturer, and the name and address of the representative if the application is made by the manufacturer;
(b)
A written statement certifying that the same application has not been filed with another conformity assessment body;
(c)
The technical documentation referred to in s. 10.
4.
The conformity assessment body shall examine the technical documentation to assess the adequacy of the technical design of the device with regard to the aspects of the essential requirements of this order for which The examination is requested.
5.
The conformity assessment body shall draw up an evaluation report listing the activities carried out in accordance with the c. 4 and their results. Without prejudice to its obligations to OFCOM, the conformity assessment body shall disclose the contents of this report, in whole or in part, only with the agreement of the manufacturer.
6.
Type Examination Certificate
6.1
Where the type meets the requirements of this order which are applicable to the device concerned, the conformity assessment body shall issue a type examination certificate to the manufacturer. This certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements of this order covered by the examination, the possible conditions of its validity and the data necessary for the examination. Identification of the approved type. One or more schedules may be attached to the type examination certificate.
6.2
The type examination certificate and its annexes shall contain all the information necessary to enable the conformity assessment of the devices manufactured to the type examined and the control in service.
6.3
Where the type does not meet the applicable requirements of this order, the conformity assessment body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, stating the reasons for its refusal.
7.
Follow-up obligations
7.1
The conformity assessment body shall follow the evolution of the generally accepted state of the art; where this evolution suggests that the approved type may no longer be in conformity with the applicable requirements of this order, It determines whether further examinations are required. If this is the case, the conformity assessment body shall inform the manufacturer accordingly.
7.2
The manufacturer shall inform the conformity assessment body which holds the technical documentation relating to the type examination certificate of all modifications of the approved type which may call into question the conformity of the device to the Essential requirements of this order or the conditions of validity of this certification. These amendments require further approval in the form of a supplement to the original type examination certificate.
8.
Information obligations
8.1
Each conformity assessment body shall inform the OFCOM of the type examination certificates and/or additions thereto which it has issued or withdrawn and shall, periodically or upon request, provide it with the list of certificates and/or additions thereto Refused, suspended or subject to other restrictions.
8.2
Each conformity assessment body shall inform other conformity assessment bodies of the conformity of type examination certificates and/or supplements which it has refused, withdrawn, suspended or subject to other restrictions and, on request, Certificates and/or supplements it has issued.
8.3
OFCOM and other conformity assessment bodies may, upon request, obtain a copy of the type examination certificates and/or their supplements. Upon request, OFCOM may obtain a copy of the technical documentation and the results of the reviews carried out by the conformity assessment body. The conformity assessment body shall keep a copy of the type examination certificate, its annexes and additions, as well as the technical file, including the documentation provided by the manufacturer until the validity of the This certificate.
9.
The manufacturer shall make available to the OFCOM a copy of the type examination certificate, its annexes and additions, as well as the technical documentation, for a period of ten years from the time the device was placed on the market.
10.
The manufacturer's representative may submit the application referred to in c. 3 and meet the obligations set out in c. 7 and 9 as long as they are specified in the terms of reference.

II Conformity to type on the basis of internal manufacturing control (module C)

1.
Conformity to the type on the basis of the internal control of manufacture is the part of the conformity assessment procedure by which the manufacturer fulfils the obligations laid down in the c. 2 and 3 and assures and declares that the devices concerned conform to the type described in the type examination certificate and meet the requirements of this order which are applicable to them.
2.
Manufacturing
2.1
The manufacturer shall take all necessary measures to ensure that the manufacturing process and its follow-up ensures the conformity of the devices manufactured to the approved type described in the type examination certificate and the requirements of this order which Are applicable to them.
2.2
The manufacturer shall take due account of changes in the design or characteristics of the device as well as modifications of the harmonised standards or other technical specifications to which the conformity of the device is Declared.
3.
Brand and Declaration of Conformity
3.1
The manufacturer shall affix the mark of conformity on each device which complies with the type described in the type examination certificate and satisfies the applicable requirements of this order.
3.2
The manufacturer shall establish, in writing, a declaration of conformity for each device model.
4.
Agent
4.1
The manufacturer's obligations under c. 3 may be complied with by its representative, on its behalf and under its responsibility, provided that they are specified in the terms of reference.
4.2
The design and manufacture of equipment and the establishment of technical documentation shall not be delegated to the agent.

Status June 13, 2016

Annex 4

(art. 11, para. 1)

Compliance Reporting Template

1 The declaration of conformity for a device bearing the Swiss conformity mark according to Annex 1, c. 1, should be based on the following model:

Title: Declaration of Conformity

1.
Apparat/product model (product number, type, lot or series number):
2.
Name and address of manufacturer or agent established in Switzerland:
3.
This declaration of conformity shall be established under the sole responsibility of the manufacturer.
4.
Purpose of the declaration (identification of the device allowing traceability; if necessary, a sufficiently clear colour image can be attached to identify the device):
5.
The purpose of the declaration described above is in accordance with the applicable Swiss law:
6.
References of relevant technical standards which have been applied, including their date, or other technical specifications, including their date, in relation to which conformity is declared:
7.
Where appropriate, the conformity assessment body ... (name, identification number) carried out ... (description of the intervention) and established the certificate:
8.
Additional information:
Signed by and on behalf of:
(date and place of establishment):
(name, function) (signature):

2 The declaration of conformity for a device bearing the foreign conformity mark according to Annex 1, c. 2, shall be established in accordance with the model set out in Annex IV to Directive 2014 /30/EU 1 .


1 Directive 2014 /30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States concerning electromagnetic compatibility (recast version), OJ L 96, 26.02.2014, p. 79.


Status June 13, 2016