The ergonomics, harmlessness, display of body measurements, wear and tear, compatibility, and labeling of protective clothing (coveralls, aprons, etc.) encompass the general performance requirements for the information provided by the manufacturer along with the protective clothing. Protective clothing should not adversely affect the user's health or hygiene. Materials should not release substances known to be toxic, carcinogenic, mutagenic, allergenic, toxic to reproduction, or otherwise harmful under foreseeable normal usage conditions.
The design of protective clothing (coveralls, aprons, etc.) should ensure that the clothing stays in place for the foreseeable duration of use, taking into account the user's proper adjustment of the clothing, comfort in movement and posture during work or other activities, as well as environmental factors. For this purpose, appropriate means such as sufficient adjustment systems or size ranges should be provided to allow the protective clothing (coveralls, aprons, etc.) to fit the user's morphology. If defined in the specific standard, the design of protective clothing should ensure that no part of the body is exposed during movements expected of the user (for example, the jacket should not rise above the waist when the arms are extended upwards). Special standards for protective clothing should include test criteria.
In the design of protective clothing (coveralls, aprons, etc.), care should be taken to ensure that other protective clothing or equipment pieces that must be worn to form a complete protective set are provided by the same manufacturer. When one or more pieces are worn together, these pieces must be compatible and each must conform to its own standard. None of them should reduce the performance of the other piece(s), and adequate protection should be provided in the interface areas between products such as the sleeve and glove, pants and shoes, and hood and protective mask combinations. Each specific standard should define the minimum mechanical properties to assess the durability of the garment. Protective clothing should provide the user with a comfort level that is compatible with the required level of protection against the hazards present during the anticipated duration of use, taking into account environmental conditions and the user's activity level.
Under the 2016/425 (EU) Personal Protective Equipment Regulation, the following standards provide the framework for the testing and CE certification services offered by Astor Mayer Certification, Inspection, and Training Services Inc. for protective clothing evaluated in CATEGORY III.
EN ISO 13688 Protective clothing - General requirements
EN 149 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
EN 13034 Protective clothing against liquid chemicals – Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)
EN 14126 Protective clothing - Performance requirements and test methods for protective clothing against infective agents
EN 14605 Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])
EN 1073-1 Protective clothing against solid airborne particles including radioactive contamination - Part 1: Requirements and test methods for compressed air line ventilated protective clothing, protecting the body and the respiratory tract
EN 1073-2 Protective clothing against radioactive contamination - Part 2: Requirements and test methods for non-ventilated protective clothing against particulate radioactive contamination
EN 1149-1 Protective clothing - Electrostatic properties - Part 1: Test method for measurement of surface resistivity
EN 1149-2 Protective clothing - Electrostatic properties - Part 2: Test method for measurement of the electrical resistance through a material (vertical resistance)
EN 1149-3 Protective clothing - Electrostatic properties - Part 3: Test method for measurement of charge decay
EN 1149-5 Protective clothing - Electrostatic properties - Part 5: Material performance and design requirements
EN ISO 13982-1 Protective clothing for use against solid particulate chemicals - Part 1: Performance requirements for chemical protective clothing providing protection to the full body against airborne solid particulate chemicals (type 5 clothing)
EN 14683 Medical face masks - Requirements and test methods
ASTM F 1671-97a, Resistance of Materials to Penetration by Blood-Borne Pathogens, for Use with Elastomeric Materials
ASTM F1671 - 97b Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System (Enterobacteria phage phiX174)
ASTM F2100 - 19 Standard Specification for Performance of Materials Used in Medical Face Masks
ISO 16603 Clothing for protection against contact with blood and body fluids — Determination of the resistance of protective clothing materials to penetration by blood and body fluids — Test method using synthetic blood
VDI 6022 CERTIFICATION
COSMETIC-GMP CERTIFICATION
HYGIENIC PRODUCT CERTIFICATION
CE CERTIFICATION
CODEX ALIMENTARIUS Conformity Certificate
FOOD CONFORMITY CERTIFICATION
HALAL PRODUCT CERTIFICATION
MATERIAL CONFORMITY EVALUATION AND APPROVAL
VEGAN PRODUCT CERTIFICATION
ORGANIC AND NATURAL COSMETIC CERTIFICATE
DOCUMENTS
You can access the documents via the link below.
DOCUMENTS
CE CERTIFICATION
CE MARKING REGULATION
PART ONE
Purpose and Scope, Legal Basis, and Definitions
Purpose and Scope
ARTICLE 1 — (1) The purpose of this Regulation is to establish the conformity assessment modules that regulate the methods of affixing the "CE" mark to products and the procedures and principles for the use of this mark.
(2) In the case of the existence of a technical regulation that does not foresee a conformity assessment module or EC Declaration of Conformity, the provisions of that technical regulation shall prevail.
Legal Basis
ARTICLE 2 — (1) This Regulation is prepared based on Article 14 of the Law No. 4703 on the Preparation and Implementation of Technical Legislation Related to Products, dated 29/6/2001.
Definitions
ARTICLE 3 — (1) In the application of this Regulation:
a) EC: The European Community,
b) Finished product: A product that is ready for use without requiring further processing,
c) "CE" mark: A mark indicating that the product complies with all relevant rules of the technical legislation concerning the affixing of the "CE" mark,
ç) Distributor: A natural or legal person, other than the manufacturer and importer, who places a product on the market and is part of the supply chain,
d) Manufacturer: A natural or legal person who manufactures or has designed or manufactured a product and markets it under their name or trademark,
e) Importer: A natural or legal person established in Turkey who places a product on the domestic market from abroad,
f) Commission: The European Commission,
g) Module: Each of the conformity assessment methods listed in Annex-3 of this Regulation,
ğ) Notified body: A conformity assessment body located in Turkey, designated by an authority to carry out conformity assessment activities within the scope of a technical regulation, and notified to the Commission,
h) Placing on the market: The act of making a product available on the domestic market through a commercial transaction, either for payment or free of charge, for distribution, consumption, or use,
ı) Placing on the domestic market: The first placing of a product on the domestic market,
i) Pictogram: A symbol on the product representing a characteristic related to the product,
j) Standard: A document that establishes the most suitable level of order for a product's properties, processing or manufacturing methods, or related terminology, symbols, packaging, marking, labeling, or conformity assessment processes, recognized by a national or international standardization body,
k) Technical regulation: Any legislation that establishes mandatory requirements for the properties, processing or manufacturing methods of a product, or related terminology, symbols, packaging, marking, labeling, or conformity assessment processes,
l) Technical specification: A document specifying the technical conditions that a product, process, or service must meet,
m) Type: A sample representing the product to be manufactured,
n) Conformity assessment: The process of verifying whether certain requirements are met for a product, process, service, system, person, or organization,
o) Conformity assessment body: A conformity assessment organization located in Turkey, which conducts activities such as calibration, testing, certification, and inspection,
ö) Harmonized standard: A standard prepared and accepted by a European standardization organization at the request of the Commission, in accordance with the Regulation on the Notification of Technical Legislation and Standards Between Turkey and the European Union published in the Official Gazette on 3/4/2002,
p) Harmonized national standard: A standard accepted by the Turkish Standards Institute as a harmonized national standard from among harmonized standards,
r) Competent authority: A public body authorized by law or regulatory measures to prepare or implement regulations related to a product or product group or to monitor these products,
s) Authorized representative: A natural or legal person established in Turkey, who has received written authorization from the manufacturer to carry out specific duties on their behalf.
SECOND SECTION
Obligations of the Parties
Obligations of the Manufacturer
ARTICLE 4 — (1) The manufacturer is responsible for preparing the technical file required by the relevant technical regulation, conducting or having the conformity assessment procedures carried out, preparing the EC Declaration of Conformity, affixing the "CE" mark on the product, and keeping the technical file and the EC Declaration of Conformity for the duration specified in the relevant technical regulation, or for ten years from the date the product is placed on the market in cases where no duration is specified, and submitting them to the competent authority upon request, subject to other obligations set out in the relevant technical regulation.
Obligations of the Authorized Representative
ARTICLE 5 — (1) The authorized representative, as specified in the written power of attorney granted by the manufacturer, and subject to other obligations defined in the relevant technical regulation, fulfills the manufacturer's obligations outlined in Article 4, except for preparing the technical file.
Obligations of the Importer
ARTICLE 6 — (1) The importer, subject to other obligations defined in the relevant technical regulation, is required to confirm that the manufacturer has fulfilled the obligations listed in Article 4, verify that the product carries the "CE" mark, keep a copy of the EC Declaration of Conformity for ten years from the date the product is placed on the market, and submit it to the competent authority upon request. The importer must also provide a copy of the technical file upon request to the competent authority.
Situations Where the Manufacturer's Obligations Apply to Importers and Distributors
ARTICLE 7 — (1) Importers and distributors who place a product on the market under their name or trademark, or who modify a product that has already been placed on the market in a way that affects its compliance with the relevant technical regulation, are considered manufacturers under this Regulation and are required to fulfill the obligations outlined in Article 4.
THIRD SECTION
Conformity Assessment Procedures, Affixing and Use of the "CE" Mark, EC Declaration of Conformity
Conformity Assessment Procedures
ARTICLE 8 — (1) In order for a product to be placed on the market, it must undergo the conformity assessment procedures foreseen in the relevant technical regulation or regulations, and these procedures must yield positive results.
Affixing and Use of the "CE" Mark
ARTICLE 9 — (1) The general principles regarding the affixing and use of the "CE" mark on a product are as follows:
a) The manufacturer, by affixing or ensuring the affixing of the "CE" mark on the product, declares that the product complies with the relevant technical regulation(s) that require the "CE" mark and has undergone all the necessary conformity assessment procedures.
b) If a product is subject to more than one technical regulation that requires the affixing of the "CE" mark, the "CE" mark on the product serves as a presumption that the manufacturer has fulfilled all the applicable provisions of these technical regulations. If any of these technical regulations provide for a transition period and give the manufacturer a choice of application, the "CE" mark indicates compliance only with the provisions of the technical regulation(s) that have been applied.
c) The "CE" mark:
Shall consist of the letters "CE" in the form specified in Annex 1 and must not be altered except for reducing or enlarging it in accordance with the proportions shown in the drawing.
Shall be at least 5 mm in size unless otherwise specified in the relevant technical regulation.
Shall be affixed to the product, its information plate, or its packaging, or, where this is not possible or its permanence cannot be ensured, on the packaging, and on the accompanying documents required by the relevant technical regulation, in a visible, legible, and indelible manner.
ç) The "CE" mark shall be affixed before the product is placed on the market.
d) The "CE" mark shall only be affixed by the manufacturer or its authorized representative.
e) Where required by the relevant technical regulation, the identity registration number of the notified body involved in the production control phase shall be placed next to the "CE" mark. The identity registration number may be affixed by the notified body itself, or by the manufacturer or its authorized representative under the notified body's instructions.
f) The "CE" mark may also be accompanied by pictograms or other markings that describe a specific risk or usage associated with the product.
g) No other markings or descriptions that could mislead third parties regarding the meaning and form of the "CE" mark may be placed on the product. Other markings may only be placed on the product in such a way that the visibility, legibility, and meaning of the "CE" mark are not impaired.
ğ) The "CE" mark can only be used on products that are subject to technical regulations that require it, and cannot be used on products that are not covered by such regulations.
EC Declaration of Conformity
ARTICLE 10 — (1) Unless otherwise specified in the relevant technical regulation, the EC Declaration of Conformity shall be prepared in at least the content required by the relevant module or modules, and in accordance with the example provided in Annex-2. If prepared in other languages, a Turkish translation must also be included. The declaration shall be updated whenever necessary.
(2) In cases where a product is subject to multiple technical regulations requiring an EC Declaration of Conformity, the manufacturer shall demonstrate that it has fulfilled all applicable rules of these technical regulations by issuing a single EC Declaration of Conformity. The declaration text must include the name, publication date, and reference number of these technical regulations.
(3) By preparing and signing the EC Declaration of Conformity, the manufacturer assumes responsibility for ensuring that the product complies with the rules of the relevant technical regulation.
Conformity Assessment Modules
ARTICLE 11 — (1) Except for the second paragraph of Article 1, if a technical regulation requires conformity assessment for a specific product, the applicable method shall be selected from the conformity assessment modules regulated in Annex-3.
(2) Which module or modules from Annex-3 will be followed shall be specified in the relevant technical regulation.
FOURTH SECTION
Various Provisions
Equivalence of Foreign Authorized Representatives
ARTICLE 12 — (1) Authorized representatives established in European Union member countries are considered equivalent to authorized representatives established in Turkey, based on the principle of reciprocity.
(2) In order for an authorized representative established outside Turkey and the European Union to be considered equivalent, a mutual recognition agreement must exist between the European Union and the country where the authorized representative is established. Additionally, a similar agreement must be concluded between Turkey and this third country and come into force in accordance with the procedure.
Implementation
ARTICLE 13 — (1) The provisions of this Regulation apply together with the technical regulations that foresee the affixing of the "CE" mark on the product.
Penalties
ARTICLE 14 — (1) Administrative fines, as specified in Law No. 4703, will be imposed on those who violate the provisions of this Regulation.
Revoked Legislation
ARTICLE 15 — (1) The "CE" Marking Regulation for Products, issued with the Cabinet Decision No. 2001/3530 on 15/11/2001, has been repealed. References to the mentioned Regulation in the relevant legislation are deemed to be references to this Regulation.
Entry into Force
ARTICLE 16 — (1) This Regulation enters into force on the date of its publication.
Execution
ARTICLE 17 — (1) The provisions of this Regulation are executed by the Council of Ministers.
ANNEX-1
CE MARK
The "CE" mark consists of the letters "CE" in the shape and proportions shown below:
In cases where it needs to be reduced or enlarged, the proportions in the diagram above must be followed.
Unless otherwise specified in the relevant technical regulation, the "CE" mark shall be at least 5 mm in size.
ANNEX-2
EXAMPLE OF EC DECLARATION OF CONFORMITY
No …………. (Number distinguishing the product from others):
Name and address of the manufacturer or authorized representative:
This declaration of conformity has been issued under the manufacturer's (or the person performing the installation's) own responsibility. (Name of the manufacturer or installer):
Subject of the declaration (Provide a description of the product in a way that allows traceability. A photograph may be added if appropriate):
The subject of the declaration described above complies with the following legislation. (Name of the legislation): …………………………………………………………….
References to the relevant harmonized national standards or references to the technical specifications declared for compliance:
Name and identity registration number of the notified body involved and issuing the ……………. certificate (with a description of the type of conformity assessment activity performed)
Additional information:
Signed for or on behalf of .........................................
(Location and date of preparation)
(Name, title/position) (Signature)
ANNEX-3
Conformity Assessment Methods
Module A – Internal Control of Production
ARTICLE 1 — (1) Internal control of production is a conformity assessment method where the manufacturer ensures, under its own responsibility, that its products comply with the relevant rules of the technical legislation, and declares compliance by meeting the obligations listed in the second, third, and fourth paragraphs.
(2) The manufacturer prepares a technical file that allows the assessment of the product's compliance with the relevant rules and includes sufficient analysis and evaluation of the risks. The technical file specifies the applicable rules for the product and includes the design, manufacturing, and operation of the product, insofar as it is relevant to the assessment. In every applicable case, the technical file includes at least the following:
a) A general description of the product.
b) Conceptual design and manufacturing drawings, as well as diagrams of components, parts, circuits, and similar elements.
c) Descriptions and explanations necessary for understanding the functioning of the product based on these drawings and diagrams.
ç) A list of the reference names of harmonized national standards and/or relevant technical specifications that have been partially or completely applied, as well as descriptions of solutions adopted to meet the essential requirements of the relevant technical regulation in cases where these standards have not been applied. If harmonized national standards are partially applied, the sections of these standards that have been applied should be identified.
d) Results of design calculations, inspections, and similar activities.
e) Test reports.
(3) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the technical file mentioned in the second paragraph and the relevant rules of the technical legislation.
(4) The manufacturer:
a) Affixes the conformity marking, as required by the relevant technical regulation, to every product that complies with the relevant rules of this regulation.
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, and provides it to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers.
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(5) The obligations in the fourth paragraph may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the delegation.
Module A1 – Internal Control of Production and Controlled Product Testing
ARTICLE 2 — (1) Internal control of production and controlled product testing is a conformity assessment method where the manufacturer ensures, under its own responsibility, that its products comply with the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations outlined in the second, third, fourth, and fifth paragraphs.
(2) The manufacturer prepares a technical file that allows the assessment of the product's compliance with the relevant rules and includes sufficient analysis and evaluation of the risks. The technical file specifies the applicable rules for the product and includes the design, manufacturing, and operation of the product, insofar as it is relevant to the assessment. In every applicable case, the technical file includes at least the following:
a) A general description of the product.
b) Conceptual design and manufacturing drawings, as well as diagrams of components, parts, circuits, and similar elements.
c) Descriptions and explanations necessary for understanding the functioning of the product based on these drawings and diagrams.
ç) A list of the reference names of harmonized national standards and/or relevant technical specifications that have been partially or completely applied, as well as descriptions of solutions adopted to meet the essential requirements of the relevant technical regulation in cases where these standards have not been applied. If harmonized national standards are partially applied, the sections of these standards that have been applied should be identified.
d) Results of design calculations, inspections, and similar activities.
e) Test reports.
(3) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the technical file mentioned in the second paragraph and the relevant rules of the technical legislation.
(4) Each product, or one or more elements of the product, undergoes testing by the manufacturer or on behalf of the manufacturer to verify compliance with the relevant rules of the technical legislation. These tests are conducted by an accredited in-house unit or by a notified body designated by the manufacturer, as per the manufacturer's choice. If a notified body conducts the tests, the manufacturer must place the identity registration number of the notified body on the product during the manufacturing process.
(5) The manufacturer:
a) Affixes the conformity marking, as required by the relevant technical regulation, to every product that complies with the relevant rules of this regulation.
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, and provides it to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers.
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(6) The obligations in the fifth paragraph may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the delegation.
Module A2 – Internal Control of Production and Random Interval Inspections of the Product
ARTICLE 3 — (1) Internal control of production and random interval inspections of the product is a conformity assessment method where the manufacturer ensures, under its own responsibility, that its products comply with the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations outlined in the second, third, fourth, and fifth paragraphs.
(2) The manufacturer prepares a technical file that allows the assessment of the product's compliance with the relevant rules and includes sufficient analysis and evaluation of the risks. The technical file specifies the applicable rules for the product and includes the design, manufacturing, and operation of the product, insofar as it is relevant to the assessment. In every applicable case, the technical file includes at least the following:
a) A general description of the product.
b) Conceptual design and manufacturing drawings, as well as diagrams of components, parts, circuits, and similar elements.
c) Descriptions and explanations necessary for understanding the functioning of the product based on these drawings and diagrams.
ç) A list of the reference names of harmonized national standards and/or relevant technical specifications that have been partially or completely applied, as well as descriptions of solutions adopted to meet the essential requirements of the relevant technical regulation in cases where these standards have not been applied. If harmonized national standards are partially applied, the sections of these standards that have been applied should be identified.
d) Results of design calculations, inspections, and similar activities.
e) Test reports.
(3) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the technical file mentioned in the second paragraph and the relevant rules of the technical legislation.
(4) At random intervals, an accredited in-house unit or a notified body designated by the manufacturer conducts inspections to verify the quality of the internal controls of the product, taking into account factors such as the technology level of the product and production quantity. Before placing the product on the market, a sufficient number of finished product samples are tested at the premises of the in-house accredited unit or notified body. The tests are conducted according to the relevant sections of harmonized national standards and/or technical specifications. The sampling procedure allows the manufacturer to determine whether the production process is functioning within acceptable limits to ensure product conformity.
If a notified body conducts the tests, the manufacturer must place the identity registration number of the notified body on the product during the manufacturing process.
(5) Manufacturer:
a) The manufacturer affixes the conformity mark, as required by the relevant technical regulation, to each product that complies with the applicable rules of this regulation,
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, to be provided to the competent authorities upon request. The declaration of conformity includes the description of the product it refers to,
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(6) The obligations in paragraph 5 may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the relevant delegation.
Module B – EC Type Examination
ARTICLE 4 — (1) EC type examination is a conformity assessment procedure in which a notified body examines the technical design of a product and confirms that this design complies with the relevant rules of the technical legislation and certifies it.
(2) The EC type examination can be conducted under any of the following methods:
a) Examination of a sample representing the finished version of the product (production type).
b) Examination of the technical file and supporting evidence as outlined in paragraph 3 to evaluate the adequacy of the product's technical design and the examination of one or more important parts of the sample of the product to be produced (a combination of production type and design type).
c) Evaluation of the product's technical design without examining a sample (design type) by reviewing the technical file and supporting evidence as outlined in paragraph 3.
(3) The manufacturer submits the EC type examination request to a single notified body of their choice. The application includes the following:
a) The name and address of the manufacturer; if the application is made by the authorized representative, their name and address as well,
b) A written statement confirming that the application has not been submitted to another notified body,
c) Technical file. The technical file should be adequate to evaluate the compliance of the product with the relevant rules and should include sufficient analysis and evaluation of the risks. The technical file specifies the applicable rules for the product and includes the design, manufacturing, and operation of the product as relevant to the assessment. The technical file should include at least the following:
A general description of the product,
Conceptual design and manufacturing drawings, including diagrams of components, parts, circuits, and similar elements,
Descriptions and explanations necessary for understanding the functioning of the product based on these drawings and diagrams,
A list of the reference names of harmonized national standards and/or relevant technical specifications that have been partially or completely applied, as well as descriptions of solutions adopted to meet the essential requirements of the relevant technical regulation when these standards were not applied. If harmonized national standards are partially applied, the sections of these standards that have been applied should be identified,
Results of design calculations, inspections, and similar activities,
Test reports.
ç) Samples representing the product to be produced. If necessary, the notified body may request additional samples for the test program.
d) Supporting evidence for the adequacy of the technical design solutions. This supporting evidence refers to any document, especially when the relevant harmonized national standards and/or technical specifications are not fully applied. These supporting documents may include results from tests conducted by the manufacturer’s laboratory or, on behalf of the manufacturer and under their responsibility, by another laboratory.
(4) The notified body:
a) Examines the technical file and supporting evidence to evaluate the adequacy of the product's technical design,
b) In case of a sample:
Verifies that the sample has been manufactured in accordance with the technical file and identifies elements designed according to harmonized national standards and/or technical specifications and those that were designed without applying the relevant provisions of these standards,
When the manufacturer has opted to apply the solutions in the relevant harmonized national standards and/or technical specifications, checks whether these solutions have been correctly applied by conducting or having conducted the appropriate inspections and tests,
When the relevant harmonized national standards and/or technical specifications have not been applied, conducts or arranges appropriate inspections and tests to verify whether the alternative solutions adopted by the manufacturer meet the essential requirements of the technical legislation.
(4) The manufacturer agrees with the notified body regarding the location where the inspection and testing will take place.
(5) The notified body prepares an evaluation report based on the activities carried out in paragraph 4 and their results. The notified body, without prejudice to its responsibilities to the authority that appointed it, may disclose part or all of the content of this report only with the manufacturer's consent.
(6) If the evaluated type complies with the relevant rules of the technical legislation, the notified body issues an EC type examination certificate to the manufacturer. The certificate includes the name and address of the manufacturer, the results of the examination, any conditions regarding the certificate's validity, and the necessary information to identify the approved type. The certificate may have one or more annexes. The certificate and its annexes provide all the necessary information to assess the conformity of the manufactured products with the examined type and allow for in-process control. If the type does not meet the relevant rules of the technical legislation, the notified body refuses to issue the EC type examination certificate and informs the applicant about the refusal, including detailed justifications.
(7) The notified body monitors technological advancements in the industry to determine whether such innovations indicate that the approved type no longer complies with the relevant technical legislation. If such a determination is made, the notified body informs the manufacturer. The manufacturer provides the notified body, which holds the technical file for the EC type examination certificate, with information on any modifications made to the approved type that could affect the product's compliance with the essential requirements of the relevant technical legislation or the conditions of validity for the EC type examination certificate. Such changes require additional approval and must be reflected in the EC type examination certificate.
(8) Each notified body informs the authorities that appointed it about any EC type examination certificates it has issued or withdrawn, as well as any additions to them, and provides a list of any EC type examination certificates it has refused, suspended, or otherwise restricted, as well as any additions to those certificates, upon request. Each notified body also informs other notified bodies about the EC type examination certificates it has refused, suspended, withdrawn, or otherwise restricted, and about those it has issued, upon request. The European Commission, member states of the European Union, and other notified bodies can obtain a copy of the EC type examination certificates and/or any additions to them. Upon request, the Commission and member states of the European Union may also obtain a copy of the technical file and the examination results conducted by the notified body. The notified body keeps a copy of the EC type examination certificate, its annexes, and the technical file, including documents provided by the manufacturer, until the validity period of the EC type examination certificate expires.
(9) The manufacturer keeps a copy of the EC type examination certificate, its annexes, and any additions, along with the technical file, for ten years from the date the product is placed on the market, and provides them to the competent authorities upon request.
(10) The manufacturer's authorized representative may submit the application mentioned in paragraph 3 and fulfill the obligations specified in paragraphs 7 and 9, provided that it is indicated in the relevant delegation.
Module C – Conformity Based on Internal Control of Production
ARTICLE 5 — (1) Conformity based on internal control of production is a conformity assessment process in which the manufacturer ensures, under its own responsibility, that the products comply with the type defined in the EC type examination certificate and the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations in paragraphs 2 and 3.
(2) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the approved type, as defined in the EC type examination certificate, and with the relevant rules of the technical legislation.
(3) The manufacturer:
a) Affixes the conformity mark, as required by the relevant technical regulation, to each product that complies with the type defined in the EC type examination certificate and the relevant rules of this regulation,
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, to be provided to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers,
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(4) The obligations listed in paragraph 3 may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the relevant delegation.
Module C1 – Conformity Based on Internal Control of Production and Controlled Product Testing
ARTICLE 6 — (1) Conformity based on internal control of production and controlled product testing is a conformity assessment process in which the manufacturer ensures, under its own responsibility, that the products comply with the type defined in the EC type examination certificate and the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations listed in paragraphs 2, 3, and 4.
(2) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the approved type, as defined in the EC type examination certificate, and with the relevant rules of the technical legislation.
(3) Each product or one or more components of the product is subjected to one or more tests by the manufacturer or on its behalf to verify compliance with the relevant rules of the technical legislation. These tests are conducted by an accredited in-house unit or by a notified body designated by the manufacturer, based on the manufacturer's choice. When the tests are conducted by a notified body, the manufacturer affixes the notified body’s identity registration number to the product during the manufacturing process, under the responsibility of that body.
(4) The manufacturer:
a) Affixes the conformity mark, as required by the relevant technical regulation, to each product that complies with the type defined in the EC type examination certificate and the relevant rules of this regulation,
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, to be provided to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers,
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(5) The obligations listed in paragraph 4 may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the relevant delegation.
Module C2 – Conformity Based on Internal Control of Production and Random Interval Inspections of the Product
ARTICLE 7 – Conformity Based on Internal Control of Production and Random Interval Inspections of the Product
(1) Conformity based on internal control of production and random interval inspections of the product is a conformity assessment process in which the manufacturer ensures, under its own responsibility, that its products comply with the type described in the EC type examination certificate and the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations listed in paragraphs 2, 3, and 4.
(2) The manufacturer takes all necessary measures to ensure that the manufacturing process and its supervision guarantee the conformity of the produced products with the approved type, as defined in the EC type examination certificate, and with the relevant rules of the technical legislation.
(3) Based on the manufacturer's selection, an accredited in-house unit or a notified body designated by the manufacturer conducts random inspections, considering factors such as the product's technological level and production volume, to verify the quality of the product's internal controls. To verify compliance with the relevant rules of the technical legislation before placing the product on the market, sufficient samples of finished products taken on-site by an accredited in-house unit or a notified body are examined, and the relevant tests specified in the applicable harmonized national standards and/or technical specifications are conducted. If the sample does not meet the acceptable quality level, the notified body takes necessary measures. The sampling procedure allows for determining whether the manufacturing process is operating within acceptable limits for ensuring the product’s conformity. When the tests are conducted by a notified body, the manufacturer affixes the identity registration number of the notified body to the product during manufacturing, under the responsibility of the notified body.
(4) The manufacturer:
a) Affixes the conformity mark, as required by the relevant technical regulation, to each product that complies with the type described in the EC type examination certificate and the relevant rules of this regulation,
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, to be provided to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers,
c) Provides a copy of the declaration of conformity to the competent authorities upon request.
(5) The obligations in paragraph 4 may be fulfilled by the authorized representative on behalf of the manufacturer, as long as it is done under the manufacturer's responsibility and is specified in the relevant delegation.
Module D – Conformity Based on the Quality Assurance of the Manufacturing Process
ARTICLE 8 – (1) Conformity based on the quality assurance of the manufacturing process is a conformity assessment process in which the manufacturer ensures, under its own responsibility, that its products comply with the type described in the EC type examination certificate and the relevant rules of the technical legislation, and declares compliance by fulfilling the obligations listed in paragraphs 2 and 5.
(2) The manufacturer operates an approved quality system for production, finished product inspection, and testing, as specified in paragraph 3, and is subject to supervision as outlined in paragraph 4.
(3) The procedures and principles related to the quality system are as follows:
a) The manufacturer applies to a notified body of its choice for the evaluation of the quality system applied to the products. The application includes the following information:
The name and address of the manufacturer; if the application is made by the authorized representative, their name and address as well.
A written statement that the same application has not been made to another notified body.
All relevant information regarding the category of the product being designed.
Documentation related to the quality system.
A copy of the technical file related to the approved type and the EC type examination certificate.
b) The quality system ensures compliance of the products with the type described in the EC type examination certificate and the relevant rules of the technical legislation. All elements, rules, and provisions adopted by the manufacturer are documented systematically and regularly in written policies, procedures, and instructions, and preserved. The documentation of the quality system is organized in a way that allows for consistent interpretation of quality programs, plans, manuals, and records. The quality system documentation contains sufficient information and explanations regarding the following:
The management’s quality goals and organizational structure, and the responsibilities and authorities regarding product quality.
Relevant manufacturing, quality control, and quality assurance techniques, processes, and systematic actions to be taken.
Inspections and tests to be performed before manufacturing, during manufacturing, and after manufacturing, along with the frequency of these actions.
Quality records such as inspection reports, test and calibration data, and qualifications of relevant personnel.
Tools for monitoring the achievement of the desired product quality and the effective functioning of the quality system.
c) The notified body evaluates the quality system to determine whether it meets the conditions specified in paragraph (b). The notified body assumes that the quality system elements conform to the relevant rules of the applicable harmonized national standard and/or technical specification. In addition to experience with quality management systems, at least one member of the audit team must have experience in evaluating the product area, product technology, and knowledge of the relevant technical rules. The audit includes a visit to the manufacturer’s premises. The audit team reviews the technical file referred to in subparagraph (5) of paragraph (a) to verify the manufacturer’s ability to identify the relevant technical rules and ensure the conformity of the product with those rules. The notified body informs the manufacturer of its decision. The notification includes the results of the audit and reasoned evaluations regarding the decision.
ç) The manufacturer commits to fulfilling the obligations arising from the approved quality system and to maintaining the quality system in a sufficient and effective manner.
d) The manufacturer informs the notified body that approved the quality system of any proposed changes to the system. The notified body evaluates the proposed changes and decides whether the modified quality system still meets the conditions specified in paragraph (b) or if a new evaluation is required. The notified body informs the manufacturer of its decision. The notification includes the results of the evaluation and reasoned assessments regarding the decision.
(4) The procedures and principles for supervision under the responsibility of the notified body are as follows:
a) The purpose of supervision is to ensure that the manufacturer fully complies with the obligations arising from the approved quality system.
b) The manufacturer allows the notified body to enter its manufacturing facilities, inspection and testing laboratories, and storage areas to carry out the evaluation and provides the necessary information, particularly the following:
Documentation related to the quality system.
Quality records such as inspection reports, test and calibration data, and qualifications of relevant personnel.
c) The notified body conducts periodic audits to verify that the manufacturer is maintaining and applying the quality system and issues an audit report to the manufacturer.
ç) Additionally, the notified body may visit the manufacturer without prior notice. During these visits, the notified body may conduct or have conducted product tests to verify the proper functioning of the quality system. The notified body issues a visit report and, if applicable, a test report to the manufacturer.
(5) The manufacturer:
a) Affixes the conformity mark and, under the responsibility of the notified body as mentioned in subparagraph (a) of paragraph 3, affixes the identity registration number of the notified body to each product that complies with the type described in the EC type examination certificate and the relevant rules of the technical regulation,
b) Prepares a written declaration of conformity for each product model and keeps this declaration, along with the technical file, for ten years from the date the product is placed on the market, to be provided to the competent authorities upon request. The declaration of conformity includes the description of the product to which it refers,
c) Provides a copy of the declaration of conformity to the competent authorities upon request.