xmlns:atom="http://www.w3.org/2005/Atom" xmlns:atom="http://www.w3.org/2005/Atom"
examination of a specimen, representative of the production envisaged, of the complete instrument (production type);
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the instrument (combination of production type and design type);
assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in point 1.3, without examination of a specimen (design type).
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation. The technical documentation shall make it possible to assess the instrument’s conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The technical documentation shall contain, wherever applicable, at least the following elements:
a general description of the instrument;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports;
the specimens representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme;
the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer or by another testing laboratory on his behalf and under his responsibility.
For the instrument:
examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;
For the specimen(s):
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of this Directive;
agree with the manufacturer on a location where the examinations and tests will be carried out.
The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured instruments with the examined type to be evaluated and to allow for in-service control.
The EU-type examination certificate shall have a validity period of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each. In the event of fundamental changes to the design of the instrument, e.g. as a result of the application of new techniques, the validity of EU-type examination certificate may be limited to two years and extended by three years.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the instruments concerned as specified in point 2.3, and shall be subject to surveillance as specified in point 2.4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the instrument category envisaged;
the documentation concerning the quality system; and
the technical documentation of the approved type and a copy of the EU-type examination certificate.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 2.3.1(e) to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 2.3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
the documentation referred to in point 2.3.1;
the information relating to the change referred to in point 2.3.5, as approved;
the decisions and reports of the notified body referred to in points 2.3.5, 2.4.3 and 2.4.4.
The manufacturer’s obligations set out in points 2.3.1, 2.3.5, 2.5 and 2.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the instrument’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the instrument. The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the instrument;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the instruments concerned as specified in point 3.5, and shall be subject to surveillance as specified in point 3.6.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
all relevant information for the instrument category envisaged;
the documentation concerning the quality system;
the technical documentation referred to in point 3.2.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.2 in order to verify the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.5.2 or whether reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the technical documentation referred to in point 3.2;
the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
the documentation referred to in point 3.5.1;
the information relating to the change referred to in point 3.5.5, as approved;
the decisions and reports of the notified body referred to in points 3.5.5, 3.6.3 and 3.6.4.
The manufacturer’s obligations set out in points 3.3, 3.5.1, 3.5.5, 3.7 and 3.8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the approved type described in the EU-type examination certificate and with the requirements of this Directive that apply to them.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests in order to check the conformity of the instruments with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The examinations and tests to check the conformity of the instruments with the appropriate requirements shall be carried out by examination and testing of every instrument as specified in point 4.4.
In the absence of such a harmonised standard, the notified body concerned shall decide on the appropriate tests to be carried out.
The manufacturer shall keep the certificates of conformity available for inspection by the national authorities for 10 years after the instrument has been placed on the market.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
If the notified body referred to in point 4.3 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in point 4.2.
a general description of the instrument;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instruments with the applicable requirements of this Directive.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests to check the conformity of the instruments with the applicable requirements of this Directive.
The examinations and tests to check the conformity with those requirements shall be carried out by examination and testing of every instrument as specified in point 5.5.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
If the notified body referred to in point 5.5 agrees and under its responsibility, the manufacturer may also affix the notified body’s identification number to the instruments.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer’s obligations set out in points 5.2.1 and 5.3.
a general description of the instrument;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the instrument;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Directive, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
results of design calculations made, examinations carried out, etc.;
test reports.
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured instrument with the applicable requirements of this Directive.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the instrument with the applicable requirements of this Directive, or have them carried out. In the absence of such a harmonised standard the notified body concerned shall decide on the appropriate tests to be carried out.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved instrument, or have it affixed under its responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for 10 years after the instrument has been placed on the market.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer’s obligations set out in points 6.2.2 and 6.5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The party which carries out the second stage of the procedure shall carry out those examinations and tests that have not yet been carried out.
The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.