EU CE마킹 제도

CE( ) 마킹 제도
1. 개 요
□ CE( ) 마킹의 의미
CE 마킹은 소비자의 위생, 안전 및 환경 보호를 규정한 관련 EU 규정
에서 제시하는 필수요건에 적합하다는 것을 적합성평가를 통해 확인되었다는
것을 의미하며, CE 마킹대상 품목을 유럽 시장에 판매하고자 하는
제조자들은 의무적으로 부착하여야

부착 함
※CE 마킹은 프랑스어 “"Conformité Européene" 의

머리글자로 ”European Conformity(유럽적합성)"의 의미.
당초에는 EC 마킹으로 사용되었으나 1993년에 Directive
93/68/EEC1)에 의해 CE 마킹으로 대체
☞ CE 마킹은 품질마크의 일종이 아니라 주로 안전성에 관련되는 것
□ 공통적용 국가
○CE마킹은 유럽연합(EU) 25개국과 유럽자유무역연합(EFTA

유럽자유무역연합(EFTA : European
Free Trade Association) 3개국(*스위스는 제외)에서 통용(총 28개국)
- 이들 국가에서는 제품의 설계 및 제조와 관련된 요구사항이 해당
제품에 관한 EU 지침에 의해 단일규정이 적용
1)Directive 93/68/EEC에 대해서는

http://ec.europa.eu/enterprise/electr_equipment/emc/directiv/93_68_eec.pdf 참조
2. CE 마킹 대상품목 및 관련 EU 지침(EU Directive)
□ CE 마킹대상은 22개
22개 제품군이 대상이
대상 되며, 상기 EU 회원국 및
EFTA 국가 시장판매시 CE 마킹이 필수적
(1) 장난감(Toy)
○ 관련지침 : Council Directive 88/378/EEC of 3 May 1988 on the

approximation of the laws of the Member States concerning the safety of toys
(http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1988/L/01988L0378-19930802-en.pdf 참조)
- 발효일 : 1990. 1. 1일부터 발효
(2) Machinery(기계류)
○ 관련지침 : Directive 98/37/EC of the European Parliament and of

the Council of 22 June 1998 on the approximation of the laws of the
Member States relating to machinery
- 발효일 : 1993. 1. 1일부터 발효, 1995.1.1일부터 부착 의무화
(3)가스용품(Appliances Burning Gaseous Fuels (AppliGas))
○ 관련지침 : Council Directive of 29 June 1990 on the approximation of

the laws of the Member States relating to appliances burning gaseous
fuels(90/396/EEC)
(90/396/EEC)
- 2 -
(4)공중케이블(삭도) 설치(Cableway Installations to Carry Persons)
○ 관련지침 : Directive 2000/9/EC relating to cableway installations

for persons
(http://eur-lex.europa.eu/LexUriServ/site/en/oj/2000/l_106/l_10620000503en00210048.pdf 참조)
(5)저전압 전기장비(Low Voltage Electrical Equipment)
○ 관련지침 : Council Directive of 19February 1973 on the harmonization

of the laws of Member States relating to electrical equipment
designed for use within certain voltage limits(73/23/EEC)
(http://europa.eu/eur-lex/en/consleg/pdf/1973/en_1973L0023_do_001.pdf 참조)
(6)건자재(Construction Products)
○ 관련지침 : Council Directive of 21 December 1988 on the

approximation of laws, regulations and administrative provisions of
the Member States relating to construction products(89/106/EEC)
(7)폭발 위험이 있는 대기중에서 사용되는 장비나 보호 장치

(Equipment and protective systems intended for use in potentially explosive atmospheres)
○ 관련지침 : Directive 94/9/EC of the European Parliament and the

Council of 23 March 1994 on the approximation of the laws of the
Member States concerning equipment and protective systems intended
for use in potentially explosive atmospheres
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31994L0009:EN:HTML 참조)
- 3 -
(8)민수용 폭발물(Explosives for Civil Uses)
○ 관련지침 : Council Directive 93/15/EEC of 5 April 1993 on the

harmonization of the provisions relating to the placing on the market
and supervision of explosives for civil uses
(9)새로운 온수 보일러(New Hot Water Boilers)
○ 관련지침 : Council Directive 92/42/EEC of 21 May 1992 on

efficiency requirements for new hot-water boilers fired with liquid
or gaseous fuels
(10)승강기(Lift)
○ 관련지침 : Directive 95/16/EC of the European Parliament and of

the Council of 29 June 1995 on the approximation of the laws of the
Member States relating to lifts
(11)의료기기(Medical Devices)
○ 관련지침 : Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

- 4 -
(12)능동형(배터리 장착) 인체이식용 의료장치(Active Implantable Medical Devic)
○ 관련지침 : Council Directive 90/385/EEC of 20 June 1990 on the approximation of

the laws of the Member States relating to active implantable medical devices
(13)체외 진단 시약/기기(In Vitro Diagnostic Medical Devices )
○ 관련지침 : Directive 98/79/EC of the European Parliament and of the Council of 27

October 1998 on in vitro diagnostic medical devices
(14)비자동 계량기(Non-automatic Weighing Instruments)
○ 관련지침 : Council Directive 90/384/EEC of 20 June 1990 on the harmonization

of the laws of the Member States relating to non-automatic weighing instruments
(15)무선장비 및 통신터미널장비
(Radio Equipment & Telecommunications Terminal Equipment (R&TTE))
○ 관련지침 : Directive 1999/5/EC on Radio Equiment and Telecommunications

Terminal Equipment and the mutual recognition of their conformity
(16)개인보호장비(Personal Protective Equipment)
○ 관련지침 : Council Directive 89/686/EEC of 21 December 1989 on the approximation

of the laws of the Member States relating to personal protective equipment
- 5 -
(17)단순 압력용기(Simple Pressure Vessels)
○ 관련지침 : Council Directive 87/404/EEC of 25 June 1987 on the harmonization of

the laws of the Member States relating to simple pressure vessels
(18)압력장비(Pressure Equipment)
○ 관련지침 : Directive 97/23/EC of the European Parliament and of the

Council of 29 May 1997 on the approximation of the laws of the Member States
concerning pressure equipment
(19)가정용 냉장고(Household Refrigerators & Freezers)
○ 관련지침 : Directive 96/57/EC of the European Parliament and of the

Council of 3 September 1996 on energy efficiency requirements for household
electric refrigerators, freezers and combinations
(20)레저용 보트(Recreational Craft)
○ 관련지침 : Directive 2003/44/EC amending Directive 94/25/EC relating to

recreational craft
- 6 -
(21)전자파 적합성 제품(Electromagnetic compatibility (EMC))
○ 관련지침 : Directive 2004/108/EC relating to electromagnetic

compatibility and repealing Directive 89/336/EEC
(22)계량기(Measuring instruments)
○ 관련지침 : European Parliament and Council Directive 2004/22/EC of 31

March 2004 on measuring instruments (applicable from 2006-10-30)
※ CE 마킹과 관련된 지침, 가이드, 설명자료는 EU 집행위원회 홈페이지 참조

(http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html 참조)
3. CE마킹 획득 절차
□ 제 1단계 : 제조자의 상품에 해당되는 지침(Directive)을 찾아 볼 것
○ 상기 개별지침 또는 다음의 European Union 웹싸이트에서 다운로드 가능

(http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist.html 참조)
○ 만약 하나 이상의 지침이 적용되는 경우, 이들 모두를 충족해야 함
*예) 저전압지침(73/23/EEC : Low Voltage Directive)과 전자파지침(89/336/EEC : EMC

Directive)에 모두 해당한다면 해당 규격에 따른 시험 및 결과를 사용하여 적합성을 증명하고
CE마킹을 하여야 함
- 7 -
□ 제 2단계 : 적용가능한 지침에 있는 디자인 및 제작의 필수요건
(essential requirements)에 자신의 제품이 부합하는 정도를 확인
□ 제 3단계 : 해당 제품의 지침에서 정한 평가모듈로 부터 적합성

평가절차(the conformity assessment procedure)를 선택
○ 적합성평가는 평가모듈에 기초하며, 평가모듈은 ①제조자/제3자(공인

검정(시험)기관)가 개입하는지 ②제품의 디자인/생산 단계, 또는 두단계
모두와 관련한 것인지에 따라 8가지 기본모듈(basic modules)로 구분
- 기본모듈외에 모듈간 조합이 된 변형모듈(Variants

변형모듈(Variants of basic
modules)도
modules) 존재
○ 제조자는 지침에서 정하는 모듈을 적용하여야

적용 하며, 동일제품군의 지침내
에서는 몇 가지 모듈중에서 선택할

선택 수 있도록 하는 경우도 있음
※ 모듈에 관한 EU 규정은 93/465/EEC: 93/465/EEC Council Decision of 22 July 1993

concerning the modules for the various phases of the conformity assessment
procedures and the rules for the affixing and use of the CE conformity
marking,
marking, which are intended to be used in the technical harmonization
directives 참조
(http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993D0465:EN:HTML 참조)
- 8 -
【참고 1】기본모듈(Basic Modules)
모듈유형 내 용 운용형태
․ 내부 디자인 및 생산 통제에 적용.

모듈 A : 내부생산통제 ․ 공인시험기관(Notified Body : NB)의 검사 불요
․
(Internal control of production)
기술문서2) 작성및자신의적합성공표문3)으로 CE마킹
․
디자인 단계 적용.
․
모듈 B : EC 형식 검정
생산단계의 모듈(C,D,E,F)평가가 후속되어야 함
․
(EC type-examination)
NB에
NB 의해 EC형식검정 증명서가 발급됨
․
생산단계에 적용되며,
적용 모듈 B에 후속됨
모듈 C : 형식 적합성 ․
모듈 B에 의해 발급된 EC형식검정 증명서상
B+C
(Conformity to type) 기술된 형식에의 적합성 여부 규정
․ NB의 어떠한 조치도 요구하지 않음
․ 생산단계에 적용되며,
모듈 D : 생산품질보증 ․ 품질보증표준인 EN ISO 9002에 기초
(Production quality assurance) ․ 생산, 최종제품검사 및 테스트를 위한 품질
B+D
․
시스템의 승인통제 책임이 있는 NB가 개입
모듈 E : 제품품질보증 ․ 품질보증표준인 EN ISO 9003에 기초
(Product quality assurance) ․ 최종제품검사 및 테스트를 위한 품질시스템의
B+E
․
승인통제 책임이 있는 NB가 개입
․ NB가 EC형식검정 증명서에 기술된 형식의
모듈 F : 제품 검정
B+F
(Product verification)
적합성을 통제하고 적합성 증명서를 발급
모듈 G : 단위 검정 ․ 디자인 및 생산단계에
생산단계 적용
(Unit verification) ․ 개별제품은 NB가 검정하고 적합성 증명서를 발급
․ 디자인 및 생산단계에
생산단계 적용
모듈 H : 전체품질보증 ․ 품질보증표준인 EN ISO 9001에 기초
(Full quality assurance) ․ 디자인,제조, 최종제품검사 및 테스트를 위한
․
품질시스템의 승인통제 책임이 있는 NB가 개입
2) 기술문서(Technical
기술문서(Technical documentation)의
documentation) 내용은 각 지침별로 규정되어 있으며, 대체로 제조자가 제조자 제품의 디자인,
제조, 운영에 관한 사항이며 관련 지침에서 정하고 있는 필수요건(essential requirement)에 해당 제품의 적합성을 보여
주기 위한 것으로 각 지침에서 달리 정하지 않는 한 제품의 최종 제조일로부터 최소한 10년간 보관되어야 함
3) 적합성공표문(declaration
적합성공표문(declaration of conformity)는
conformity) 적합성 평가절차의 일부분으로 제조자 또는 승인받은 대리자가대리자 작성
하며, 형태는 문서, 라벨 또는 이에 상응하는 방식으로 나타나며(이에 관한 표준은 EN 45014 참조), 최소한 제조자
또는 승인받은 대리자의 이름과 주소, 제품 명세(이름, 형식 혹은 모델번호, 기타 관련 부수정보), 국내기술표준
이나 사양과 같은 참조표준의 모든 관련 조항, 공표문의 발급일자와 승인된 자의 서명이나 직책, 공표문이 제
조자(및 승인받은 대리자)의 단독 책임하에 발급되었다는 내용 등이 포함되어야 함. 이 경우에도 각 지침에서
달리 정하지 않는 한 제품의 최종 제조일로부터 최소한 10년간 보관되어야 함
- 9 -
【참고 2】모듈(적합성평가) 유형의 도해
* 상세 도해는 【붙임# 1】
1】참조
* 모듈(적합성평가절차)의 상세 내용 및 제품군별 모듈 적용에 관한 설명은 EU 집행위가
발간한 “Guide to the implementation of directive based on the New
Approach and the Global Approach"중
Approach" 붙임에 첨부한 Annex 7(Contents 7 of
conformity assessment procedures) 및 annex 8(Flow 8 chart presentation of
conformity assessment procedures as provided for by the directive) 참조
(전체원문은http://ec.europa.eu/enterprise/newapproach/legislation/guide/document/1999_1282_en.pdf 참조)
【참고 3】기본모듈에 대한 변형(Variants of basic modules)
변형유형 내용 NB의 개입
․ 내부 생산 통제와 완성품에 대한 하나이상의
제조자또( 는 대리인에
) 의해 수행
Aa1 & Cbis1 되는 테스트에 대하여 디자인
특정 측면에 대한 하나이상의 테스트
혹은생산단계중하나에 NB가개입
․ 내부 생산 통제와
통제 불규칙한 간격으로 생산단계에서의 제품검사에
Aa2 & Cbis2
제품 검사(product checks) NB가 개입
Dbis ․ 모듈 B를 사용하지 않는 생산품질보증 기술문서 필요
Ebis ․ 모듈 B를 사용하지 않는 제품품질보증 기술문서 필요
Fbis ․ 모듈 B를 사용하지 않는 제품검정 기술문서 필요
․ 디자인 통제를 하는 전제품질보증
NB가 제품의 디자인을 분석하고
Hbis
EC 디자인 검정증명서를 발급
- 10 -
☞ 공인검정기관(Notified
공인검정기관(Notified Body : NB)
ㅇ 대부분의 지침은 제품의 특성에 따라 위험(risk)의 수준을 분류하는데 극소의

위험(Minimal Risk)을 가진 제품은 자기 검증(제조자가 적합성공표문을 작성)을
하고 자신의 제품에 CE마킹을 부착
- 반면, 상당한 위험(greater risk)가 있는 제품에 대해서는 NB에 의한

독립적인 인증을 받도록 요구
ㅇ NB는 개별 회원국 정부가 추천하고 EU Commission에 의해 공인된

독립적인 시험기관으로서 지침상의 조치를 수행
- 지침에서 정한 시험요건을 충족하는 필요한 자격요건을 가져야 하며 민간조직

민간조직
또는 정부기관 모두 가능
- 통상, NB는 제품 테스트, 형식검정 인증서 발급, 기술파일 및 디자인 서류
평가,
평가, 제품 및 제품 및 품질시스템의 감독, 표준 확인 등의 기능을 수행
ㅇ 제조기업들은 어떠한 EU 회원국에 있는 NB를 선택할 수 있으며,

European Commission는 NB를 “Official Journal of the EU”에 공표
※ 각 NB 현황에 대해서는
http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=notifiedbody.main 참조
□ 제 4단계 : 만약 제품이 공인검정기관(NB)의 인증이 필요한 경우
다음에 따라 조치
① 적용가능한 제품 표준 및 테스트 방법과 NB를 선택
② EU 내에 승인된 대리인(Authorized Representative)을 지정
- 몇몇 지침은 제조자가 기술문서(Technical Documentation, 때로는 Technical
File로 불림)를 적절한 방법으로 작성제출할 수 있는 승인된 대리인을
EU내에 지정하도록 요구
- 11 -
③ 적합성공표문(DoC
적합성공표문(DoC : Declaration of Conformity)을
Conformity) 준비
※ 적합성공표문(DoC) 모델
④ EU내에서 제품을 등록
- 많은 제품들(예, Class I Medical Devices)이 EU내에 등록이 필요하며
등록요건이 입증되면 등록증명서(Crtificate of Registration)를 받게 됨
- 등록증명서가 없는 경우, CE마킹 부착과 시장 판매가 허용되지 않음
- 12 -
⑤ 제품에 CE 마킹을 부착
- CE 마킹은 Directive 93/68/EEC의

93/68/EEC 규정에 따라 부착
* CE마킹의 크기, 부착위치, 포장 및 재료 혹은 제품의 선적 서류, CE마
킹 부착이 허용되는 때․사람에 대한 구체적인 제한사항 등을 규정
(http://ec.europa.eu/enterprise/electr_equipment/emc/directiv/93_68_eec.pdf 참조
※ 상품에 판매되어질 국가가 순수하게 자국내에서

자국내에서 요구하는 다른 사항(
사항(국내표준,
레벨 또는 포장 필요요건 등)도 확인이 필요
4. 다른 국가와의 상호인증(Mutual Recognition)
□ EU는 미국, 일본, 캐나다, 오스트레일리아, 뉴질랜드, 스위스, 이스라엘과
상호인증협정(MRA : Mutual Recognition Agreements )을 체결
○ 상호인증협정은 상대방의 적합성평가기관(CAB

적합성평가기관(CAB : Conformity
Assessment Body)의 시험보고서, 인증서 및 마크 등을 인정하는
조건을 규정
※ 이에 관해서는 http://ec.europa.eu/enterprise/international/index_en.htm 참조
5. CE 마킹과 다른 마크와의 관계
□ CE마킹은 국가별로 존재하던 적합성 마킹을 대체하기 때문에 CE마킹과
동일한 의미를 가지는 개별 국가의 적합성 마킹은 위법
○ 따라서, 회원국은 CE마킹을 자국내 규정 및 행정절차에 반영 의무화
□ 그러나, CE마킹과 다른 기능을 수행하고 혼란을 야기하지 않는
추가적 마킹은 가능
- 13 -
6. CE마킹과 정부조달
□ EU시장에 진출하려는 제3국의 제조업자는 CE마킹 대상품목에 해당할

경우 이의 획득이 필수적
○ 일부제품(해당 모듈)의 경우, ISO 9000 품질인증을 획득하는 경우

CE 마킹 획득에 유리
□ EU 공공조달시장에 진출하려는 경우에도 동일하게 적용
○ EU 공공조달시장에 관심이 있는 우리기업들도 CE마킹 적용여부

확인 및 적용시 제품의 요건 충족과 CE마킹 획득에 대한 정보 수집이 요망됨
* 컴퓨터, Fax, 모델, 무선장비, 전화기, 스케너, 프린터, 각종 전자제품 등 행정사무용

기기 등은 대부분 해당
- 14 -
【붙임#
붙임# 1】 모듈(적합성평가) 유형의 상세 도해
❝ Guide to the implementation of directives based on the New Approach and the Global Approach ❞
Annex 7
Contents of conformity assessment procedures
Council Decision 93/465/EEC lays down the modules for conformity assessment, which are further defined in each direc-
tive. This annex is intended to give an overview of the tasks that are to be carried out under the responsibility of the manu-
facturer and the notified body, and the tasks that the manufacturer can delegate to the authorised representative. However,
there are differences between the conformity assessment procedures adopted by the directives, which are not taken into
account in this general presentation. Furthermore, the tasks to be carried out by the importer or the person responsible for
placing on the market are described in Section 3.3. of the Guide.
Module Manufacturer Manufacturer or the Notified body

authorised representative
A • establishes a technical docu- • ensures and declares that
mentation as regards the the products concerned
design, manufacture and satisfy the requirements
operation of the product • affixes the CE marking to
• takes all measures neces- each product
sary to ensure that the manu- • draws up a declaration of
facturing process assures conformity
compliance of the products • keeps a copy of the declara-
with the technical documen- tion of conformity and the
tation and with the applicable technical documentation at
requirements (i.e. operates a the disposal of the surveil-
quality system) lance authorities
Aa1 In addition to the responsibili- In addition to the responsibili- • supervises the tests carried
ties as in module A: ties as in module A: out by the manufacturer
• carries out, or has carried • affixes the notified body’s • supervises the affixing of its
out on his behalf, one or identification number to identification number, where
more tests for each product follow the CE marking, if the it was involved in conformity
manufactured notified body intervened assessment during the pro-
• chooses a notified body on during the production stage duction stage
whose responsibility the tests • keeps a record of relevant
are carried out information
• communicates to the other
notified bodies relevant infor-
mation (on request)
Aa2 As in module A: In addition to the responsibili- • carries out or has carried out
• applies for product checks at ties as in module A: product checks at random in-
random intervals • affixes the notified body’s tervals, and for this purpose
identification number to takes samples of final products
follow the CE marking • supervises the affixing of its
identification number
• keeps a record of relevant
information
mation (on request)
B • establishes a technical • applies for the EC type- • ascertains, by performing or
documentation as regards examination having performed examina-
the design, manufacture and • places at the disposal of the tions and tests, that the spec-
operation of the product notified body one (or more) imen(s) meet(s) the applicable
specimen(s), which is (are) provisions and is manufac-
representative of the produc- tured in accordance with the
tion envisaged technical documentation
• informs the notified body of • issues an EC type-examina-
all modifications to the tion certificate
approved product • keeps a copy of the certifi-
• keeps the technical docu- cate and a record of other
mentation, including a copy relevant technical information
of the EC type-examination • communicates to the other
certificate, at the disposal of notified bodies the relevant
the surveillance authorities information concerning the
EC type-examination certifi-
cates (on request)
84
❝ Annex 7 ❞

C • takes all measures neces- • ensures and declares that
sary to ensure that the manu- the products concerned are
facturing process assures in conformity with the EC
compliance of the products type-examination certificate
with the type as described in and satisfy the applicable
the EC type-examination cer- requirements
tificate and with the applica- • affixes the CE marking to
ble requirements (i.e. oper- each product
ates a quality system, which • draws up a declaration of
includes establishing the conformity
necessary documentation) • keeps relevant technical
information and a copy of the
declaration of conformity at
the disposal of the surveil-
lance authorities
Cbis1 As in modules C and Aa1 As in modules C and Aa1 As in module Aa1
Cbis2 As in modules C and Aa2 As in modules C and Aa2 As in module Aa2
D • operates an approved quality • affixes the CE marking to • assesses the quality system
system for production, final each product to determine whether it satis-
product inspection and • affixes the notified body’s fies the applicable require-
testing, which includes the identification number to ments, and accordingly takes
drawing up of a technical follow the CE marking a decision
documentation (i.e. relevant • draws up a declaration of • supervises the affixing of its
information for the product conformity identification number
category envisaged, docu- • informs the notified body of • carries out surveillance of the
mentation concerning the any intended updating of the manufacturer by means of
quality system and its updat- quality system periodic and unexpected
ing, technical documentation • keeps a copy of the declara- visits
of the approved type, a copy tion of conformity at the • keeps a record of relevant
of the EC type-examination disposal of the surveillance technical information
certificate, and the decisions authorities • communicates to the other
and reports from the notified notified bodies the relevant
body) information concerning the
• applies for the assessment quality system approvals
of the quality system for the issued and withdrawn (on
products concerned request)
• ensures and declares that
the products concerned are
in accordance with the EC
type-examination certificate
and satisfy the applicable
requirements
• undertakes to fulfil the obliga-
tions arising out of the
approved quality system and
upholds it so that it remains
adequate and efficient
• supports the action carried
out by the notified body for
surveillance purpose
• keeps at the disposal of the
surveillance authority the
documentation concerning
the quality system, details of
any updating of the quality
system, the decisions and
reports of the notified body
85

Dbis • establishes a technical docu- As in module D As in module D
mentation as regards the de-
sign, manufacture and opera-
tion of the product
• operates an approved quality
system for production, final
product inspection and
testing, which includes the
drawing up of a technical
documentation (i.e. relevant
information for the product
category envisaged, docu-
mentation concerning the
quality system and its updat-
ing, and the decisions and
reports from the notified body)
• applies for the assessment of
the quality system for the
products concerned
• ensures and declares that
the products concerned
satisfy the requirements
• undertakes to fulfil the
obligations arising out of the
surveillance authority the doc-
umentation concerning the
quality system, details of any
updating of the quality sys-
tem, the decisions and re-
ports of the notified body
E As in module D, but operates As in module D As in module D
an approved quality system for
final product inspection and
testing
Ebis As in module Dbis, but operates As in module D As in module D
an approved quality system for
final product inspection and
testing
F • takes all measures neces- • applies for certification of • carries out the appropriate
sary to ensure that the manu- conformity examinations and tests in
facturing process assures • checks and attests that the order to check the conform-
conformity of the products products are in conformity ity of the product with the
with the type as described in with the type as described in applicable requirements
the EC type-examination the EC type-examination either by examination and
certificate and with the ap- certificate and satisfy the testing of every product, or
plicable requirements (i.e. applicable requirements by examination and testing of
operates a quality system, • affixes the CE marking to products on a statistical
which includes establishing each product basis
the necessary documenta- • affixes the notified body’s • supervises the affixing of its
tion) identification number to identification number
follow the CE marking • draws up a certificate of
Where the statistical verification • draws up a declaration of conformity relating to the
is used: conformity tests carried out
• presents the products in the • keeps relevant technical • if a lot is rejected, takes
form of homogeneous lots information (e.g. the notified appropriate measures to
and takes all measures body’s certificate of conform- prevent the putting on the
necessary in order that the ity) and a copy of the decla- market of that lot
manufacturing process ration of conformity at the • keeps a record of relevant
ensures the homogeneity of disposal of the surveillance technical information
each lot produced authorities • communicates to the other
notified bodies relevant
information (on request)
86
❝ Annex 7 ❞

Fbis • establishes a technical docu- • applies for certification of As in module F
mentation as regards the conformity
design, manufacture and • checks and attests that the
operation of the product products satisfy the applica-
• takes all measures neces- ble requirements
sary to ensure that the manu- • affixes the CE marking to
facturing process assures each product
conformity of the products • affixes the notified body’s
with the applicable require- identification number to
ments (i.e. operates a quality follow the CE marking
system) • draws up a declaration of
conformity
Where the statistical verification • keeps a copy of the declara-
is used: tion of conformity, the techni-
• presents the products in the cal documentation and the
form of homogeneous lots notified body’s certificate of
and takes all measures conformity at the disposal of
necessary in order that the the surveillance authorities
manufacturing process
assures the homogeneity of
each lot produced
G • establishes a technical • applies for certification of • examines the individual
documentation as regards conformity product, and carries out the
the design, manufacture and • affixes the CE marking to appropriate tests to ensure
operation of the product each product its conformity with the
• ensures and declares that • affixes the notified body’s relevant requirements
the product concerned identification number to • supervises the affixing of its
conforms to the applicable follow the CE marking identification number
requirements • draws up a declaration of • keeps a record of relevant
conformity information
• keeps a copy of the declara- • draws up a certificate of
tion of conformity and the conformity concerning the
technical documentation at tests carried out
the disposal of the surveil- • communicates to the other
lance authorities notified bodies relevant
information (on request)
H • operates an approved quality As in module D As in module D
system for design, manufac-
ture, final product inspection
and testing, which includes
the drawing up of a technical
documentation (i.e. relevant
information for the design,
the product category envis-
aged, documentation con-
cerning the quality system
and its updating, and the
decisions and reports from a
notified body)
• applies for the assessment
of the quality system for the
products concerned
• ensures and declares that the
products concerned satisfy
the applicable requirements
• undertakes to fulfil the obliga-
tions arising out of the
surveillance authority the
documentation concerning
the quality system, details of
any updating of the quality
system, the decisions and
reports of the notified body
87

Hbis In addition to responsibilities as As in module D In addition to responsibilities as
in module H: in module D:
• applies for examination of the • examines the application
design • issues an EC design examina-
• informs the notified body of tion certificate, if the design
any modification to the meets the applicable provi-
approved design sions
• keeps a record of the EC
design examination certifi-
cates and the EC design
approvals
mation concerning the EC
design examination certifi-
cates and the EC design
approvals (on request)
88
❝ Annex 8 ❞
Annex 8
Flow chart presentation of conformity assessment procedures as provided for by the
directives
I New Approach directives

1. Low voltage equipment (73/23/EEC, amendment 93/68/EEC)
2. Simple pressure vessels (87/404/EEC, amendments 90/488/EEC and 93/68/EEC)
3. Toys (88/378/EEC, amendment 93/68/EEC)
4. Electromagnetic compatibility (89/336/EEC, amendments 92/31/EEC and 93/68/EEC)
5. Machinery (98/37/EC, amendment 98/79/EC)
6. Personal protective equipment (89/686/EEC, amendments 93/68/EEC, 93/95/EEC and 96/58/EC)
7. Non-automatic weighing instruments (90/384/EEC, amendment 93/68/EEC)
8. Active implantable medical devices (90/385/EEC, amendments 93/42/EEC and 93/68/EEC)
9. Gas appliances (90/396/EEC, amendment 93/68/EEC)
10. Hot water boilers (92/42/EEC, amendment 93/68/EEC)
11. Civil explosives (93/15/EEC)
12. Medical devices (93/42/EEC, amendment 98/79/EC)
13. Potentially explosive atmospheres (94/9/EC)
14. Recreational craft (94/25/EC)
15. Lifts (95/16/EC)
16. Refrigeration appliances (96/57/EC)
17. Pressure equipment (97/23/EC)
18. Telecommunications terminal equipment (98/13/EC)
19. In vitro diagnostic medical devices (98/79/EC)
20. Radio and telecommunications terminal equipment (99/5/EC)
II Directive based on the principles of the Global Approach, but which does not provide for the CE marking
21. Marine equipment (96/98/EC)
89
1. Flow chart for the conformity assessment procedures provided for in
Directive 73/23/EEC on electrical equipment designed for use within certain voltage limits
EC declaration of conformity
Technical File (Annex IV.3) (Internal Production Control - Annex III. B).
Manufacturer establishes the Manufacturer ensures and declares
MANUFACTURER technical documentation covering compliance of manufactured products with
the design, manufacture and technical documentation and with Directive
90
operation of the electrical equipment requirements.
Module A
NB: In the event of a challenge the manufacturer may submit a ‘report by a notified body’ on the conformity of the equipment with the safety objectives (Article 8.2).
Directive 87/404/EEC on simple pressure vessels
Certification of
file adequacy EC Verification (Art. 11)
by NB PS. V > NB verifies and certifies SPV
3000 bar.L conformity. Manufacturers
MODULE A+ (*) declare the conformity.
Manu- MODULE F (*)

Value
facturer’s of PS. V
Yes choice
EC type
examination
(Art.10) PS. V <
3000 bar.L
MODULE B (*)
Com-
pliance with
standards
PS. V >
50 bar.L
91
EC conformity declaration,
by manufacturers,
plus EC surveillance by NB
❝ Annex 8 ❞
No or if PS. V>200 bar.L (Art. 12).

partial
MODULE Cbis2+
Function
MANUFACTURER of value PS. V Manu-
(Art. 3.2 facturer’s
& 8.1) choice
Manufacture in
PS. V < accordance with No CE
50 bar.L sound engineering marking
practice (Art. 3.2)
(*) These procedures were approved before the adoption of Council Decision 90/683/EEC (as amended by Decision 93/465/EEC) on conformity assessment procedures (modules).
Their provisions may therefore not be identical to those of the modules.
Directive 88/378/EEC on the safety of toys
Manufacturer keeps technical file

or technical report, ensuring
conformity of production
to standard (Art. 8)
MODULE A (*)
Yes
Compliance
MANUFACTURER
92
with
standards
Non-compliance,
in whole or in part
Manufacturer confirms
EC type-examination conformity of production with
(Art. 10) type and keeps technical file or
technical reports inspection (Art. 8.2)
MODULE B (*)
MODULE C (*)
Directive 89/336/EEC on electromagnetic compatibility
Full Self certification (Art. 10.1) EC declaration of conformity

application MODULE A (*) by manufacturer
Application
of harmonised
standards
Other than
radio transmitters
93
❝ Annex 8 ❞
Non-application or
partial application of
harmonised standards
Type
MANUFACTURER of product Technical construction Technical report or
file (Art. 10.2) certificate by a
by manufacturer competent body (Art. 10.2)
EC declaration of
EC type-examination
Radio conformity with type
(Art 10.5)
transmitters approved
MODULE B (*)
MODULE C (*)
Directive 98/37/EC on machinery
EC conformity declaration
Technical construction with essential requirements
file (Annex V)
MODULE A
Not referred
to in Annex IV
Type Referred to in Annex IV,

of machines and without meeting or only EC type examination (1)
MANUFACTURER safety components partly meeting the (Annex VI)
standards, or if no such MODULE B (*)
(Annex IV) standards exist
94
Referred to
in Annex IV
and complying Technical file (Annex VI)
with standards sent to notified body Conformity declaration to type
covered by the EC type examination
MODULE A
Type
Technical file (Annex VI)
of machines and
submitted to NB for
safety components
certification of adequacy
(Annex IV) for the file
(1) Safety components do not

bear CE marking. All machines
and safety components
EC type-examination must be accompanied by
(Annex VI) the EC declaration of
conformity.
MODULE B (*)
Directive 89/686/EEC on personal protection equipment (PPE)
to essential requirements (Art. 12)
MODULE A (*)
Simple design
PPE (Art. 8.3)
Other to type (Art. 12)
equipment
MODULE C (*)
Technical file Type of

MANUFACTURER (Annex III) product
Type of
product
95
❝ Annex 8 ❞
(EC final product quality
Other
system (Art. 11A))
equipment
NB carries out product checks
MODULE C bis2 (*)
Complex design
PPE (Art. 8.4a)
Manu-
EC type-examination facturer’s
(Art. 10) choice
MODULE B (*) EC declaration of conformity

(EC production quality system
(Art 11B))
NB assesses and monitors
the manufacturer’s quality
system.
MODULE D (*)
Directive 90/384/EEC on non-automatic weighing instruments
with type (product quality
Instruments Manu- assurance - Annex II.2)
Art. 8.1a facturer’s NB assesses and monitors the
2nd para choice manufacturer’s quality system
MODULE D (*)
EC type-examination Manu-
(Annex II.1) facturer’s
MODULE B (*) choice
Art. 1.2a
EC verification (Annex II.3)
Manu- NB verifies and certifies that
facturer’s products conform to type
96
choice
MODULE F (*)
Use of
MANUFACTURER product
EC unit verification (Annex II.4)
NB verifies and certifies that instrument
meets the directive requirements.
MODULE G (*)
Art. 1.2b
The product must bear:

• the manufacturer’s mark or name No CE
• the maximum capacity marking
(Annex IV.2)
Directive 90/385/EEC on active implantable medical devices
Manufacturer’s declaration No CE
(Annex 6) marking
+ technical file
Custom made
devices and devices for
clinical investigations
Type
MANUFACTURER of product
Art. 9
(complete quality assurance
system + product design file (Annex 2))
97
NB issues an EC design examination
certificate (Annex 2, para. 4)
NB assesses and monitors the
❝ Annex 8 ❞
All other manufacturer’s quality system

devices EC declaration of conformity
MODULE Hbis (*) to type (production quality
Manu- assurance (Annex 5))
facturer’s NB assesses and monitors the
choice manufacturer’s quality system
MODULE D (*)
EC type-examination Manu-
(Annex 3) facturer’s
MODULE B (*) choice
EC verification (Annex 4)
NB verifies and certifies that
products conform to the type
MODULE F (*)
Directive 90/396/EEC on appliances burning gaseous fuels

NB verifies and certifies that the appliance
meets the directive requirements
Technical design file (Annex IV) is made
Simple design
available to the NB
PPE (Art. 8.3)
MODULE G (*)
EC conformity declaration with

the type (Annex II.2)
NB carries out spot checks on devices
Type of MODULE C (*)

MANUFACTURER
production
(1)
EC conformity declaration with the type
(production quality assurance, Annex II.3)
98
NB assesses and monitors the manu-
facturer’s quality system
MODULE D (*)
Manu-
Other facturer’s
equipment choice
EC conformity declaration with the type
(production quality assurance, Annex II.4)
EC type examination
(Annex II.1) MODULE E (*)
MODULE B (*)
EC verification (Annex II.5)
NB verifies and certifies that products (1) Fittings don’t bear
conform with the type CE marking, but they are
accompanied by a certificate.
MODULE F (*)
Directive 92/42/EEC on efficiency requirements for new hot water boilers fired with liquid or gaseous fuel
Gas-fired boilers are submitted to conformity

assessment procedures provided for in
Directive 90/396/EEC, appliances burning
gaseous fuels (Art. 7(2))
Gas-fired
boilers
EC conformity declaration with type (Annex IV).

NB carries out spot checks on appliances
Type of MODULE Cbis2

MANUFACTURER
production
99
EC conformity declaration with type
❝ Annex 8 ❞
(production quality assurance, Annex IV)

Manufacturer’s NB assesses and monitors
Liquid-fired boilers, manufacturer’s quality system
series production choice
MODULE D
EC type-examination
(Annex III)
MODULE B EC conformity declaration with type
(product quality assurance, Annex IV)
manufacturer’s quality system
MODULE E
Note: the Directive provides in Article 6 for a label system awarding the boilers energy performances.
Directive 93/15/EEC on explosives for civil uses

NB verifies and certifies that the appliance
meets the directive requirements
Technical file (Annex IV) is made
available to the NB
MODULE G
Conformity to type (Annex II.2)

NB carries out products checks
at random intervals.
MANUFACTURER Manufacturer’s MODULE Cbis2

choice
100
Production quality assurance
(Annex II.3)
MODULE D
Manu-
facturer’s
EC type examination choice
(Annex II.1) Production quality assurance
(Annex II.4)
MODULE B NB assesses and monitors the manu-
MODULE E
Product verification (Annex II. 5)

NB verifies and certifies that products
conform with the type
MODULE F
12.1. Flow chart for the conformity assessment procedures provided for in
Directive 93/42/EEC on medical devices
No
EC declaration of
Product conformity EC verification (Annex IV)
Products (*)
class I (Annex VII) NB verifies and certifies that
in Annex
+ technical file VII.5 products conform with the technical file
MODULE A Yes MODULE F
(*) Production quality assurance (Annex V)

EC declaration of NB assesses and monitors the manufacturer’s quality
conformity system. Manufacturer declares that products conform
Manu-
(Annex VII) with the technical file
facturer’s
+ technical file
Manu- choice MODULE D
Product facturer’s MODULE A
class II B choice
(*) Production quality assurance (Annex VI)
NB assesses and monitors the manufacturer’s quality
system. Manufacturer declares that products conform
with the technical file
101
Full quality assurance system (Annex II) MODULE E
❝ Annex 8 ❞

EC design verification by NB
(Annex II.4) not applicable
Product MODULE H
class II EC verification (Annex IV)
products conform with the type
MODULE F
Product Manu-
class II B facturer’s
choice Production quality assurance (Annex V)
Type of Manu- NB assesses and monitors the
MANUFACTURER product manufacturer’s quality system
facturer’s
choice MODULE D
EC type-examination
(Annex III) Product quality assurance (Annex VI)
MODULE B manufacturer’s quality system
(*) Third party assessment relates to
(a) obtention of sterile devices, to Chart 2 MODULE E
(b) metrological aspects.
Directive 93/42/EEC on medical devices (cont.)
EC verification (Annex IV)

from Chart 1 NB verifies and certifies that
products conform with the technical file
EC type-examination MODULE F
Manu-
(Annex III)
facturer’s
MODULE B choice Production Quality Assurance (Annex V)
Manu- NB assesses and monitors the manufacturer’s quality
facturer’s system. Manufacturer declares that products conform
choice with the type
MODULE D
Product
class III
Full quality assurance system (Annex II)
NB assesses and monitors the manufacturer’s quality
system. NB verifies and certifies the design
conformity
MODULE E
102
Statement concerning devices
Devices for clinical for special purposes (Annex VIII)
investigations and The manufacturer declares that No CE
custom-made devices products conform with essential marking
requirements
EC verification (Annex IV)
Medical devices, bearing MODULE F

the CE marking, Manufacturer declaration
marketed as systems according to Art. 12.2
or procedure packs (Art. 12) Production quality assurance (Annex V)
Manu- NB assesses and monitors the No
facturer’s manufacturer’s quality system complementary
choice CE marking
MODULE D
Sterile
devices
Product quality assurance (Annex VI)
MODULE E
Directive 94/9/EC on equipment and protective systems intended for use in potential explosive atmospheres
Production quality assurance (Annex IV)

EC type examination NB assesses and monitors the
Products (Annex III)
Art. 8.1 (a) manufacturer’s quality system
and Art. 8.2 MODULE B MODULE D
Manu-
facturer’s
choice Product verification (Annex V)
NB verifies and certifies that products
MODULE F
Products
Art. 8.1 (b)(i) Conformity to type (Annex VI)
Manufacturer declares that products
MODULE Cbis1
Manu-
facturer’s
choice
103
Type Production quality assurance (Annex VII) (1 )
Products NB assesses and monitors the
of
Art. 8. 1(b)
❝ Annex 8 ❞
product manufacturer’s quality system

Manu- MODULE E
MANUFACTURER facturer’s
choice
(*) (**) Internal control of production (Annex VII)
Manufacturer declares
Products conformity to the directive and
Art. 8.1 (b)(ii) communicates the technical
file to NB
Products MODULE A+
Art. 8.1 (c)
Internal control of production (Annex VIII)

Manufacturer declares conformity to the
Unit verification (Annex IX) directive and keeps the technical file
(1) No CE marking NB verifies and certifies that products
for components
meet the directive requirements MODULE A
MODULE G
(*) All referred procedures shall be applied in respect of components, with the exception of the affixing of the CE marking (Art. 8.3).
(**) Manufacturer may follow the ‘internal control of production’ (Annex VIII) procedure with regard to the safety aspects referred to in point 1.2.7 of Annex II to the Directive.
Directive 94/25/EC on recreational craft
Internal production control

Conformity to type (Annex VIII)
plus test (Annex VI)
hull < 12 m Manufacturer declares that
MODULE Aa products conform with the type
Hull
length MODULE C
EC type-examination
12 m < hull < 24 m (Annex VII)
Production quality assurance
MODULE B (Annex IX)
Manufacturer’s NB assesses and monitors the
Manufacturer’s choice manufacturer’s quality system
Boat design choice
MODULE D
categories A and B
Product verification (Annex X)

MODULE F (1 )
Components
104
in Annex II
Unit verification (Annex XI)
2.5 m < hull < 12 m the products meet the directive
requirements
MODULE G
MANUFACTURER Type of
product
Full quality assurance (Annex XII)
Boat design NB assesses and monitors the
Hull
category C manufacturer’s quality system
length
(1) Partly completed
boats are not CE MODULE H
marketed. All products
must be accompanied NO
by the EC declaration Internal production control
of conformity. 2.5 m < hull < 12 m plus tests (Annex VI)
Comply MODULE H
Boat design
with
category D
standards
2.5 m < hull < 24 m Internal production control
YES (Annex V)
MODULE A
Directive 95/16/EC on lifts
Lift designed in accordance with Final inspection (Annex VI)

a lift having undergone NB verifies and certifies that lifts meet
EC type-examination (Annex V) Directive requirements
Installer draws up a declaration of conformity
Lift designed in accordance with
Design Product quality assurance (Annex XII)
a model lift having undergone Installer’s NB assesses and monitors the installer’s
approach EC type-examination choice quality system
(Annex V) Installer draws up a declaration of conformity
Installer’s MODULE E
choice Lift designed in accordance with
a lift for which a full quality Production quality assurance (Annex XIV)
assurance system (Annex XIII) NB assesses and monitors the installer’s
was implemented, supplemented quality system
by a design examination in case Installer draws up a declaration of conformity
Lifts it does not wholly comply with
MODULE D
the harmonised standards
Unit verification (Annex X)
NB verifies and certifies that lifts meet the Directive requirements
105
MODULE G
❝ Annex 8 ❞
Full quality assurance (Annex X)

NB assesses and monitors the installer’s quality system
NB inspects the design where it is not entirely in accordance with
INSTALLER (for lifts) Safety harmonised standards
MANUFACTURER components
on lift MODULE Hbis
(for safety components)
Conformity to type with random checking (Annex XI)
NB carries out product checks at random intervals
Manufacturer draws up a declaration of conformity
EC type-examination Manu- MODULE Cbis2
(Annex V) facturer’s
choice Product quality assurance (Annex VIII)
MODULE B NB assesses and monitors manufacturer’s quality system
Manu- Manufacturer draws up a declaration of conformity
Safety
components facturer’s MODULE E
choice
Full quality assurance (Annex IX).
NB assesses and monitors manufacturer’s quality system
Manufacturer draws up a declaration of conformity
MODULE H
Directive 96/57/EC on refrigeration appliances
106
Electric mains-operated refrigerators, Internal control of production (Annex II)
MANUFACTURER frozen food storage cabinets,
food freezers, combination of these MODULE A
17. Directive 97/23/EC concerning pressure equipment
Type of equipment Vessels Fired or Piping Safety accessories Assemblies

Pressure accessories (1) otherwise Pressure accessories (2) (Annex II, point 2) ‘Global procedure’
heated (Art. 10.2)
equipment
Fluid to be contained gaseous liquid Steam or gaseous liquid

(Art. 9) d (3) n-d ( 4) d n-d superheated d n-d d n-d
water
Annex II:
Tables 1 2 3 4 5 6 7 8 9
specific categories as a
function of PS, V or DN
107
Category Applicable procedures CE marking (a) Each item making up the
❝ Annex 8 ❞
(For categories I to IV, the manufacturer must apply one of the modules assembly:
or one of the module combinations set out in the relevant category) In general: according to its category;
Category IV
SEP See Article 3.3 No (b) Integration of items:
(Sound engineering according to the highest category of
practice) equipment not considering safety
accessories;
I A; A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1 Yes For specific equipment:
II A1; D1; E1; B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1 Category of equipment to be protected (c) Protection of assembly:
III B1+D; B1+F; B+E; B+C1; H; B+D; B+F; G; H1 highest category of equipment to be
IV B+D; B+F; G; H1 protected.
(1) If classified on the basis of PS and V. See Annex II, point 3.

(2) If classified on the basis of PS and DN. See Annex II, point 3. CE marking (5)
(3) ‘d’ means dangerous fluid. See Article 9.2.1.
(4) ‘n-d’ means non-dangerous fluid. See Article 9.2.2.
(5) Within an assembly, CE marking need not be affixed to each individual item of pressure equipment.
Directive 98/13/EC relating to telecommunications terminal equipment and satellite earth station equipment

(Annex II)
NB carries out product checks
MODULE Cbis2
EC type-examination.
NB examines documentation Manu-
and tests products facturer’s
choice
MODULE B

Manu- (production quality assurance)
MANUFACTURER facturer’s (Annex II)
choice
108
MODULE D
(full quality assurance)
(Annex IV)
MODULE H
NB: For specific equipment elements the manufacturer of satellite earth station equipment may use the internal production control procedure (Module A, Annex IX) as an alternative
to the above conformity assessment procedures.
Directive 98/79/EC on in vitro diagnostic medical devices
Intended for Procedure Statement

performance according to drawn up by
evaluation Annex VIII the manufacturer
EC declaration of conformity/
full quality assurance + design
examination + verification of
manufactured products
Referred to in Manu- (Annex IV)
Yes List A of facturer’s
Annex II choice MODULE Hbis +
EC declaration of conformity/
EC type-examination production quality assurance/
(Annex V) verification of manufactured
products (Annex IV)
109
MODULE B
MODULE D +
❝ Annex 8 ❞
Manu- EC declaration of
MANUFACTURER Device covered Referred to in facturer’s conformity/full quality
by Annex II list B of choice assurance (Annex IV,
Annex II except points 4 and 6)
MODULE H
EC type-examination EC verification
(Annex V) (Annex V)
MODULE B MODULE F
Manu-
facturer’s EC declaration of
choice conformity/production
quality assurance
(Annex IV,
except point 5)
MODULE D
to Chart 2
from Chart 2
Directive 98/79/EC on in vitro diagnostic medical devices (cont.)
to Chart 1
from Chart 1
EC declaration of conformity +
Manu- examination of design
facturer’s (Annex III)
choice
MODULE A +
Yes
110
No Intended for
self testing
No (Annex III, except point 6)
MODULE A
Intended for Procedure according to Statement drawn up by

performance Annex VIII the manufacturer
evaluation
Directive 99/5/EC on radio and telecommunications terminal equipment
Internal control of production

(Annex II)
Telecommunications terminal equipment
which does not make use of the spectrum MODULE A
allocated to terrestrial/space radio Manufacturer’s
communication, receiving parts of radio choice
equipment
Internal control of production,
Manu- specific apparatus tests and
MANUFACTURER No facturer’s examination of the technical
choice construction file (Annex IV)
MODULE Aa +
111
Other than receiving parts of radio Application of
❝ Annex 8 ❞
equipment harmonised standards
Full quality assurance

Manu- (Annex II)
Yes facturer’s
choice MODULE H
Internal control of production and

specific apparatus tests
(Annex III)
MODULE Aa
At the choice of the manufacturer, compliance with the essential requirements may be demonstrated, as an alternative, using the procedures of the Directives relating to low voltage equipment
and electromagnetic compatibility respectively, where the apparatus is within the scope of these Directives (see Tables 1 and 4)
Directive 96/98/EC on marine equipment
Manu-
facturer’s
choice
Conformity to type
(Annex B)
EC type-examination
MODULE C
(Annex B)
MODULE B Production quality
Manu- assurance (Annex B)
No facturer’s
choice MODULE D
112
Product quality
Full quality assurance assurance (Annex B)
and design examination
Produced individually or (Annex B) MODULE E
MANUFACTURER in small quantities and MODULE Hbis
not in series or in mass Product verification
(Annex B)
MODULE F
Manu-
Yes facturer’s
choice
Unit verification
(Annex B)
MODULE G

EU CE마킹 제도

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

EU CE마킹 제도

Uploaded by

Copyright:

Available Formats

CE( ) 마킹 제도

CE 마킹은 소비자의 위생, 안전 및 환경 보호를 규정한 관련 EU 규정

에서 제시하는 필수요건에 적합하다는 것을 적합성평가를 통해 확인되었다는

것을 의미하며, CE 마킹대상 품목을 유럽 시장에 판매하고자 하는

제조자들은 의무적으로 부착하여야

※CE 마킹은 프랑스어 “"Conformité Européene" 의

☞ CE 마킹은 품질마크의 일종이 아니라 주로 안전성에 관련되는 것

○CE마킹은 유럽연합(EU) 25개국과 유럽자유무역연합(EFTA

- 이들 국가에서는 제품의 설계 및 제조와 관련된 요구사항이 해당

제품에 관한 EU 지침에 의해 단일규정이 적용

1)Directive 93/68/EEC에 대해서는

EFTA 국가 시장판매시 CE 마킹이 필수적

○ 관련지침 : Council Directive 88/378/EEC of 3 May 1988 on the

- 발효일 : 1990. 1. 1일부터 발효

○ 관련지침 : Directive 98/37/EC of the European Parliament and of

- 발효일 : 1993. 1. 1일부터 발효, 1995.1.1일부터 부착 의무화

(3)가스용품(Appliances Burning Gaseous Fuels (AppliGas))

○ 관련지침 : Council Directive of 29 June 1990 on the approximation of

○ 관련지침 : Directive 2000/9/EC relating to cableway installations

(5)저전압 전기장비(Low Voltage Electrical Equipment)

○ 관련지침 : Council Directive of 19February 1973 on the harmonization

○ 관련지침 : Council Directive of 21 December 1988 on the

(7)폭발 위험이 있는 대기중에서 사용되는 장비나 보호 장치

○ 관련지침 : Directive 94/9/EC of the European Parliament and the

○ 관련지침 : Council Directive 93/15/EEC of 5 April 1993 on the

(9)새로운 온수 보일러(New Hot Water Boilers)

○ 관련지침 : Council Directive 92/42/EEC of 21 May 1992 on

○ 관련지침 : Directive 95/16/EC of the European Parliament and of

○ 관련지침 : Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

○ 관련지침 : Council Directive 90/385/EEC of 20 June 1990 on the approximation of

(13)체외 진단 시약/기기(In Vitro Diagnostic Medical Devices )

○ 관련지침 : Directive 98/79/EC of the European Parliament and of the Council of 27

(14)비자동 계량기(Non-automatic Weighing Instruments)

○ 관련지침 : Council Directive 90/384/EEC of 20 June 1990 on the harmonization

○ 관련지침 : Directive 1999/5/EC on Radio Equiment and Telecommunications

(16)개인보호장비(Personal Protective Equipment)

○ 관련지침 : Council Directive 89/686/EEC of 21 December 1989 on the approximation

○ 관련지침 : Council Directive 87/404/EEC of 25 June 1987 on the harmonization of

○ 관련지침 : Directive 97/23/EC of the European Parliament and of the

(19)가정용 냉장고(Household Refrigerators & Freezers)

○ 관련지침 : Directive 96/57/EC of the European Parliament and of the

(20)레저용 보트(Recreational Craft)

○ 관련지침 : Directive 2003/44/EC amending Directive 94/25/EC relating to

○ 관련지침 : Directive 2004/108/EC relating to electromagnetic

○ 관련지침 : European Parliament and Council Directive 2004/22/EC of 31

※ CE 마킹과 관련된 지침, 가이드, 설명자료는 EU 집행위원회 홈페이지 참조

□ 제 1단계 : 제조자의 상품에 해당되는 지침(Directive)을 찾아 볼 것

○ 상기 개별지침 또는 다음의 European Union 웹싸이트에서 다운로드 가능

○ 만약 하나 이상의 지침이 적용되는 경우, 이들 모두를 충족해야 함

*예) 저전압지침(73/23/EEC : Low Voltage Directive)과 전자파지침(89/336/EEC : EMC

(essential requirements)에 자신의 제품이 부합하는 정도를 확인

□ 제 3단계 : 해당 제품의 지침에서 정한 평가모듈로 부터 적합성

○ 적합성평가는 평가모듈에 기초하며, 평가모듈은 ①제조자/제3자(공인

- 기본모듈외에 모듈간 조합이 된 변형모듈(Variants

○ 제조자는 지침에서 정하는 모듈을 적용하여야

에서는 몇 가지 모듈중에서 선택할

※ 모듈에 관한 EU 규정은 93/465/EEC: 93/465/EEC Council Decision of 22 July 1993

․ 내부 디자인 및 생산 통제에 적용.

【참고 3】기본모듈에 대한 변형(Variants of basic modules)

ㅇ 대부분의 지침은 제품의 특성에 따라 위험(risk)의 수준을 분류하는데 극소의

- 반면, 상당한 위험(greater risk)가 있는 제품에 대해서는 NB에 의한

ㅇ NB는 개별 회원국 정부가 추천하고 EU Commission에 의해 공인된

- 지침에서 정한 시험요건을 충족하는 필요한 자격요건을 가져야 하며 민간조직