CE

  What is CE Mark?

Treaty of Rome signed on March 25, 1957; European Economic Community established on January 1, 1958; Single European Act signed in December 1985 (main content: removal of technical and physical barriers to the market within the territory of Europe until December 31, 1992) → EC Council Directive 93/68/EEC of July 1993 The CE Mark was created by the Council Directive 93/68/EEC in July 1993.

■ Created to ensure the safety of products distributed within the European Economic Area (EEA).

This declaration indicates that the manufacturer, importer or a third party (e.g. certification body) has carried out the relevant conformity assessment so that the product can be distributed on the market without any restrictions.

The CE Mark does not imply product reliability or quality assurance, but rather that the product complies with the essential requirements of EU Regulations or Directives and European Standards in relation to health and safety and consumer protection.

  CE Marking Procedures

  Applicability and timing of applicable guidelines

The chart below shows the CE Mark and when it is applied.

If a product is covered by more than one guideline, all applicable guidelines must be met.

(e.g., for machinery, all mechanical and EMC guidelines had to be met in 1996, but low-voltage guidelines were added in 1997).

Directives	Guideline No.	Implementation Date	mandatory application	module application	Target Items
CE Mark Indication Method CE MARKING,etc.	93/68/EEC	95.1.1	96.12.31
low voltage Low Voltage equipment	73/23/EEC 93/68/EEC	94.8.21	96.12.31	A	AC100V, DC150V or less
Simple pressure vessel Simple Pressure Vessel	87/404/EEC 90/488/ECC	90.7.1	92.7.1	B	0.5bar or more (excluding electronic power, ships, etc.)
Toy Safety Toy Safely	88/378/EEC 93/68/EEC	90.1.1	89.12.31	A, Aa, B
Construction materials and supplies Construction Product	89/106/EEC 93/68/EEC		91.6.27	A, B, etc.	Various building materials such as cement and tiles
electromagnetic compatibility Electromagnetic Compatibility	89/336/EEC 92/31/EEC 93/68/EEC	92.1.1	95.12.31	A,B	Wireless devices and household electrical equipment
machinery Machinery	89/392/EEC 91/368/EEC 93/44/EEC 93/68/EEC	93.1.1 93.1.1 94.7.1	94.12.31 94.12.31 96.12.31	A,B	Craft / woodworking / food and other equipment and electrical tools
Personal Protective Equipment Personal Protective Equipment	89/686/EEC 93/95/EEC 93/68/EEC	95.1.1	97.1.1	B+C, B+D, C	Personal Protective Equipment
Non-automatic weight scales Non Automatic Weighting Instruments	90/384/EEC 93/68/EEC	93.1.1	02.12.31	B	Industrial/Medical General Weighing Scales
Intravitreal active medical devices Active Implant Medical Devices	90/385/EEC 93/68/EEC	93.1.1	94.12.31	B+C, B+D, H	Implantable medical devices
Gas Combustion Equipment Gas Appliance	90/396/EEC 93/68/EEC	92.1.1	95.12.31		Gas cookware and heaters, water heaters, etc.
Communication terminal equipment Telecommunications Terminai Equipment	91/263/EEC 93/68/EEC	92.11.6			FAX, modem
hot-water boiler Hot Water Boilers	92/42/EEC 93/68/EEC	94.1.1	97.12.31		Hot water boilers using oil/gas
medical equipment Medical	93/42/EEC	95.1.1	98.6.31		Various medical devices
Terrestrial Satellite Equipment Satelited Earth Station	93/97/EEC	95.5.1
munitions for civilian use	93/15/EEC	95.1.1	02.12.31		blasting powder
Explosion-proof equipment	94/9/EEC	96.3.1	02.6.30		Explosion-proof products

  About the Conformity Assessment Module

The conformity assessment module is a system that covers both the design and production phases of a product.

Evaluation methods are organized and classified into eight basic modules, and seven standard evaluation procedures are defined by combining these modules. The appropriate module can be selected according to the characteristics and requirements of each product.

Please note that if modules E, D, or H are selected, the acquisition of ISO 9000 certification is a mandatory requirement.

module	A internal production control	B Type Examination				g unit verification	indecent Full quality assurance
design	producer 1. Storage of technical documents for inspection by authorized agencies 1. Coordination of authorized institutions	Producers are required to submit to an accredited agency 1. Technical Documents 2. submit form (sample) Authorized institutions are 1. conformity check according to the essential requirements 2. testing as needed 3. EC format inspection				producer 1. Technical Document Submission	producer 1. operation of a quality system for design authorized institution 1. quality system supervision 2. design conformance verification 3. issuance of EC Design Inspection Certificate
production	producer 1. Declaration of Conformity to Necessity Requirements 2. random (unspecified interval) product checks	C form conformance	D Production Quality Assurance EN29002	E Product Quality Assurance EN29003	f Product Verification	producer 1. product submission 2. declaration of conformity 3. authorized organization to affix the CE Mark 1. conformity of each product with the requirements of the guidelines 2. issuance of conformity certification	producer 1. Quality system operation for certified manufacturing and testing 2. declaration of conformity 3. authorized organization to affix the CE Mark 1. Quality System Supervision
		producer 1. declaration of conformity with the approved format 2. affixing the CE mark authorized institution 1. product characteristic item testing 2. random product testing	producer 1. Quality system operation for manufacturing and testing 2. Declaration of conformity with the approved format 3. CE Mark Affixing authorized institution 1. Quality System Approval 2. Supervision of quality system	producer 1. quality system operation for inspection and testing 2. declaration of conformity with the approved format 3. affixing the CE mark authorized institution 1. quality system approval 2. supervision of the quality system	producer 1. Declaration of fitness for an approved form or mandatory requirement 2. CE Mark Affixing authorized institution 1. conformity check 2. issuance of conformity certification

  Requirements for Technical Documentation (TCF)

1. Documentation Language Requirements
   • Technical documents must be prepared in English or French, the official language of the EU Member States
   • Instruction manuals, operation manuals, etc. shall be prepared in the language of the country to which the products are exported.
2. retention period
   • All technical documents shall be kept for a minimum of 10 years
3. Change Management
   • In case of self-declaration: Notify the local branch office, etc. in the EU of the changes and maintain a record of the changes.
   • For audits by the certification body: Notify the certification body of the changes and undergo reassessment.

  Ex Post Facto Management Requirements

1. Type of ex-post management method
   • Selection by random sampling
   • Selection based on product type
   • Selection based on claim occurrence
   • Selection based on accident occurrence
2. Trends in Selection Methods Complaint-based selection has become the norm. This is due to the increasing number of requests from competitors to identify the cause of the problem.
3. Document Retention Requirements The DoC (Declaration of Conformities) and TCF (Technical Files) must be kept for 10 years for post-control and product liability purposes.
4. Sanctions upon detection If a violation is identified, the following sanctions will be applied
   • Payment of additional expenses
   • Payment of fine
   • Restrictive Dispositions These measures are subject to reexamination.

  CE Mark Application Guidelines and Items

1. Low voltage equipment guidelines 73/23/EEC, 93/68/EEC
2. Electromagnetic compatibility indicator 89/336/EEC
3. Mechanical pointer 98/37/EC
4. Pressure Equipment Guideline 97/23/EC
5. Personal Protection Equipment Guideline 89/686/EEC
6. Other Guidelines

  About CE Certification

Definition of CE

CE is an acronym for the French "Communauté Européenne" (English: European Community), which stands for the European Community (now the European Union).

Meaning and Role of the CE Mark

1. Compliance with legal requirements
   • Proof of compliance with the requirements of the EU Council Directive (Directive)
   • Ensures product safety from the following four perspectives
     • safety
     • health
     • environment
     • consumer protection
2. Important Notes
   • The CE Mark is not a guarantee of product quality, but rather an indication of conformity to basic safety requirements
   • Consumer safety products distributed and sold in the EU are legally required to display the CE Mark
   • Products that do not meet the requirements for the CE Mark are prohibited from sale and distribution in the EU

  Countries to which the CE Mark is applied

1. EU (European Union) member countries: 27
   Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxemburg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
2. EFTA (European Free Trade Association) member countries: 4
   Iceland, Norway, Liechtenstein, Switzerland
3. United Kingdom

  Types of CE Mark Certification and How to Obtain

1. Declaration of Conformity (DoC)

This certification method is applicable when the product is less hazardous. The following requirements must be met

• Manufacture of products in accordance with the Common EU Standard (EN)
• Declaration of Conformity (DoC)
• Proof of conformity through technical documentation
• CE mark labeling by manufacturers at their own risk

2. certification of conformity (CoC)

This certification method is required when there is a potential hazard in the product:

• Evaluation and inspection by an EU-designated certification body (Notified Body) is mandatory.
• Conformity assessment by a certification body
• CE Marking after certification

Certification Procedure

1. In the case of the DoC method
   • Conduct product testing at testing laboratories
   • Signature on the Declaration of Self-Conformity by the manufacturer's representative director
2. For CoC method
   • Conduct product testing at testing laboratories
   • Issuance of certificates by EU certification bodies

  About Medical Devices Directive 93/42/EEC

summary

The European Medical Devices Directive (MDD) is an integrated regulation on medical devices issued by The Council of the European Communities in 1993, which came into force on June 14, 1998 and sets safety standards for the manufacture and distribution of medical devices in the EU. It has been in force since June 14, 1998 and establishes safety standards for the manufacture and distribution of medical devices in the EU.

Composition of Directive

The MDD consists of the following elements

• 23 Articles
• 12 Annexes (Annexes)
• Main provisions:
  • Definition and Classification of Medical Devices
  • Details of the certification procedure
  • Essential Requirements
  • Regulations concerning market shipment
  • Reporting Obligations to EU Authorities

CE Marking Requirements

Requirements by medical device classifications:

1. Class 1 (low-risk equipment)
   • Preparation of minimum technical documentation (TCF: Technical Construction File)
   • Must be declared to the health authorities of the EU Member States
2. Class 2 and 3 (medium- and high-risk equipment)
   • Must be audited by a designated certification body (Notified Body)
   • CE Mark can be displayed after passing the examination

error control system

1. Normal management requirements
   • Manufacturer/Distributor Compliance
   • Obligation to report to the Competent Authority
   • Submission of required documents to the certification body and registration
2. Response to medical accidents
   • Operation of a rigorous post-program management system (Vigilance system)
   • A series of reporting obligations from initial to final report