The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Changes over time for: Paragraph 49

Alternative versions:

31/12/2020- Amendment

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Insertion of SchedulesE+W+S

This section has no associated Explanatory Memorandum

49. Before Schedule 2 insert—

Regulation 2

“SCHEDULE 1AE+W+SESSENTIAL REQUIREMENTS (Annex I to the Directive)

A regulated measuring instrument shall provide a high level of metrological protection in order that any party affected can have confidence in the result of measurement, and shall be designed and manufactured to a high level of quality in respect of the measurement technology and security of the measurement data.

The essential requirements that shall be met by regulated measuring instruments are set out below and are supplemented, where appropriate, by instrument-specific requirements in Schedules 1C to 1J that provide more detail on certain aspects of the general requirements.

The solutions adopted in the pursuit of the essential requirements shall take account of the intended use of the instrument and any foreseeable misuse thereof.

DEFINITIONS

Measurand	The measurand is the particular quantity subject to measurement
Influence quantity	An influence quantity is a quantity that is not the measurand but that affects the result of measurement.
Rated Operating Conditions	The rated operating conditions are the values for the measurand and influence quantities making up the normal working conditions of an instrument.
Disturbance	An influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rated operating conditions of the regulated measuring instrument. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.
Critical change value	The critical change value is the value at which the change in the measurement result is considered undesirable.
Material Measure	A material measure is a device intended to reproduce or supply in a permanent manner during its use one or more known values of a given quantity.
Direct sales	A trading transaction is direct sales if: — the measurement result serves as the basis for the price to pay; and — at least one of the parties involved in the transaction related to measurement is a consumer or any other party requiring a similar level of protection; and — all the parties in the transaction accept the measurement result at that time and place.
Climatic environments	Climatic environments are the conditions in which regulated measuring instruments may be used. To cope with climatic differences, a range of temperature limits has been defined.
Utility	A utility is regarded as a supplier of electricity, gas or water.

ESSENTIAL REQUIREMENTS

Allowable Errors

1.1. Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as laid down in the appropriate instrument-specific requirements.

Unless stated otherwise in the instrument-specific Schedules, MPE is expressed as a bilateral value of the deviation from the true measurement value.

1.2. Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as laid down in the appropriate instrument-specific requirements.

Where the instrument is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

1.3. The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the instrument is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements laid down in the appropriate instrument-specific Schedules.

1.3.1 Climatic environments

The manufacturer shall specify the upper temperature limit and the lower temperature limit from any of the values in Table 1 unless otherwise specified in Schedules 1C to 1J and indicate whether the instrument is designed for condensing or non-condensing humidity as well as the intended location for the instrument, i.e. open or closed.

Table 1

	Temperature Limits
Upper temperature limit	30 ^oC	40 ^oC	55 ^oC	70 ^oC
Lower temperature limit	5 ^oC	-10 ^oC	-25 ^oC	-40 ^oC

1.3.2 (a) Mechanical environments are classified into classes M1 to M3 as described below.

M1	This class applies to instruments used in locations with vibration and shocks of low significance, e.g. for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities, slamming doors, etc.
M2	This class applies to instruments used in locations with significant or high levels of vibration and shock, e.g. transmitted from machines and passing vehicles in the vicinity or adjacent to heavy machines, conveyor belts, etc.
M3	This class applies to instruments used in locations where the level of vibration and shock is high and very high, e.g. for instruments mounted directly on machines, conveyor belts, etc.

(b)The following influence quantities shall be considered in relation with mechanical environments:

— vibration
— mechanical shock

1.3.3. (a) Electromagnetic environments are classified into classes E1, E2 or E3 as described below, unless otherwise laid down in the appropriate instrument-specific Schedules.

E1	This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.
E2	This class applies to instruments used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.
E3	This class applies to instruments supplied by the battery of a vehicle. Such instruments shall comply with the requirements of E2 and the following additional requirements: — voltage reductions caused by energising the starter-motor circuits of internal combustion engines, — load dump transients occurring in the event of a discharged battery being disconnected while the engine is running.

(b)The following influence quantities shall be considered in relation with electromagnetic environments:

— voltage interruptions;
— short voltage reductions;
— voltage transients on supply lines and/or signal lines;
— electrostatic discharges;
— radio frequency electromagnetic fields;
— conducted radio frequency electromagnetic fields on supply lines and/or signal lines;
— surges on supply lines and/or signal lines.

1.3.4. Other influence quantities to be considered, where appropriate, are:

— voltage variation;
— mains frequency variation;
— power frequency magnetic fields;
— any other quantity likely to influence in a significant way the accuracy of the instrument.

1.4. When carrying out the tests as envisaged in these Regulations, the following points shall apply:

1.4.1 Basic rules for testing and the determination of errors

Essential requirements specified in paragraphs 1.1 and 1.2 shall be verified for each relevant influence quantity. Unless otherwise specified in the appropriate instrument-specific Schedule, these essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value.

Metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the instrument when that influence quantity is likely to occur.

1.4.2 Ambient humidity

(a)According to the climatic operating environment in which the instrument is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate.

(b)The damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate.

Reproducibility

2. The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Repeatability

3. The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Discrimination and Sensitivity

4. A regulated measuring instrument shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.

Durability

5. A regulated measuring instrument shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.

Reliability

6. A regulated measuring instrument shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.

Suitability

7.1. A regulated measuring instrument shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

7.2. A regulated measuring instrument shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

7.3. The errors of a utility measuring instrument at flows or currents outside the controlled range shall not be unduly biased.

7.4. Where a regulated measuring instrument is designed for the measurement of values of the measurand that are constant over time, the regulated measuring instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

7.5. A regulated measuring instrument shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

7.6. A regulated measuring instrument shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.

When a regulated measuring instrument has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.

Protection against corruption

8.1. The metrological characteristics of a regulated measuring instrument shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the regulated measuring instrument.

8.2. A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

8.3. Software that is critical for metrological characteristics shall be identified as such and shall be secured.

Software identification shall be easily provided by the regulated measuring instrument.

Evidence of an intervention shall be available for a reasonable period of time.

8.4. Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

8.5. For utility measuring instruments the display of the total quantity supplied or the displays from which the total quantity supplied can be derived, whole or partial reference to which is the basis for payment, shall not be able to be reset during use.

Information to be borne by and to accompany the instrument

9.1. A regulated measuring instrument shall bear the following inscriptions:

(a)manufacturer's name, registered trade name or registered trade mark;

(b)information in respect of its accuracy; and, where applicable:

(c)information in respect of the conditions of use;

(d)measuring capacity;

(e)measuring range;

(f)identity marking;

(g)number of the type examination certificate or the design examination certificate;

(h)information whether or not additional devices providing metrological results comply with the provisions of these Regulations on legal metrological control.

9.2. An instrument of dimensions too small or of too sensitive a composition to allow it to bear the relevant information shall have its packaging, if any, and the accompanying documents required by the provisions of these Regulations suitably marked.

9.3. The instrument shall be accompanied by information on its operation, unless the simplicity of the regulated measuring instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant:

(a)rated operating conditions;

(b)mechanical and electromagnetic environment classes;

(c)the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

(d)instructions for installation, maintenance, repairs, permissible adjustments;

(e)instructions for correct operation and any special conditions of use;

(f)conditions for compatibility with interfaces or regulated measuring instruments.

9.4. Groups of identical regulated measuring instruments used in the same location or used for utility measurements do not necessarily require individual instruction manuals.

9.5. Unless specified otherwise in an instrument-specific Schedule, the scale interval for a measured value shall be in the form 1 × 10ⁿ, 2 × 10ⁿ, or 5 × 10ⁿ, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

9.6. A material measure shall be marked with a nominal value or a scale, accompanied by the unit of measurement used.

9.7. The units of measurement used and their symbols shall be in accordance with the relevant enactments on units of measurement and their symbols.

9.8. All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.

Indication of result

10.1. Indication of the result shall be by means of a display or hard copy.

10.2. The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

10.3. In the case of hard copy the print or record shall also be easily legible and non-erasable.

10.4. A regulated measuring instrument for direct sales trading transactions shall be designed to present the measurement result to both parties in the transaction when installed as intended. When critical in case of direct sales, any ticket provided to the consumer by an ancillary device not complying with the appropriate requirements of these Regulations shall bear appropriate restrictive information.

10.5. Whether or not a regulated measuring instrument intended for utility measurement purposes can be remotely read it shall in any case be fitted with a metrologically controlled display accessible without tools to the consumer. The reading of this display is the measurement result that serves as the basis for the price to pay.

Further processing of data to conclude the trading transaction

11.1. A regulated measuring instrument other than a utility measuring instrument shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when:

(a)the measurement is non-repeatable; and

(b)the regulated measuring instrument is normally intended for use in the absence of one of the trading parties.

11.2. Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

Conformity evaluation

12. A regulated measuring instrument shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these Regulations.

Regulations 2, 40(2),47(1)(b) and 52(8)

SCHEDULE 1BE+W+SCONFORMITY ASSESSMENT PROCEDURES (Annex II to the Directive)

MODULE A2:E+W+SINTERNAL PRODUCTION CONTROL PLUS SUPERVISED INSTRUMENT CHECKS AT RANDOM INTERVALS

1. Internal production control plus supervised instrument checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3, 4, and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

2. The manufacturer shall establish the technical documentation set out in regulations 44 and 45. 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.

Manufacturing

3. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured instruments with the technical documentation referred to in paragraph 2 and with the requirements of these Regulations that apply to them.

Instrument checks

4. At the choice of the manufacturer, either an accredited in-house body or an approved body, chosen by the manufacturer, shall carry out instrument checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the instrument, taking into account, inter alia, the technological complexity of the instruments and the quantity of production. An adequate sample of the final regulated measuring instruments, taken on site by the body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the designated standard, and/or normative document, and/or equivalent tests set out in other relevant technical specifications, shall be carried out to verify the conformity of the instruments with the relevant requirements of these Regulations. In the absence of a relevant designated standard or normative document, the accredited in-house body or approved body concerned shall decide on the appropriate tests to be carried out.

In those cases where a relevant number of instruments in the sample do not conform to an acceptable quality level, the accredited in-house body or approved body shall take appropriate measures.

Where the tests are carried out by an approved body, the manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the UK marking and the M marking set out in these Regulations to each individual instrument that satisfies the applicable requirements of these Regulations.

5.2. The manufacturer shall draw up a written declaration of conformity for an instrument model and keep it together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument for which it was drawn up.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

A copy of the declaration of conformity shall be supplied with each regulated measuring instrument that is placed on the market. However, this requirement may be interpreted as applying to a batch or consignment rather than individual instruments in those cases where a large number of instruments is delivered to a single user.

Authorised representative

6. The manufacturer's obligations set out in paragraph 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility provided that they are specified in the mandate.

MODULE BE+W+STYPE EXAMINATION

1. ‘Type examination’ is the part of a conformity assessment procedure in which an approved body examines the technical design of an instrument and verifies and attests that the technical design of the instrument meets the requirements of these Regulations that apply to it.

2. Type examination may be carried out in either of the following manners:

(a)examination of a specimen, representative of the production envisaged, of the complete regulated measuring instrument (production type),

(b)assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 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);

(c)assessment of the adequacy of the technical design of the instrument through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type).

The approved body decides on the appropriate manner and the specimens required.

3. The manufacturer shall lodge an application for type examination with a single approved body of his choice.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)the technical documentation set out in regulations 44 and 45. The technical documentation shall make it possible to assess the instrument's conformity with the applicable requirements of these Regulations 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 application shall in addition contain, wherever applicable:

(d)the specimens, representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme;

(e)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 designated standards, and/or normative documents 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.

4. The approved body shall:

For the instrument:

4.1. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the instrument;

For the specimen(s):

4.2. 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 designated standards and/or normative documents, as well as the elements which have been designed in accordance with other relevant technical specifications;

4.3. 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 designated standards and normative documents, these have been applied correctly;

4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant designated standards, and/or normative documents have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications meet the corresponding essential requirements of these Regulations;

4.5. agree with the manufacturer on the location where the examinations and tests will be carried out.

For the other parts of the regulated measuring instrument:

4.6. examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the other parts of the regulated measuring instrument.

5. The approved body shall draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations vis-à-vis the Secretary of State, the approved body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6. Where the type meets the requirements of these Regulations, the approved body shall issue a type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The type examination certificate may have one or more annexes attached.

The type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured regulated measuring instruments with the examined type to be evaluated and to allow for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated with the examined type regarding the reproducibility of their metrological performances, when they are properly adjusted using appropriate means, content shall include:

— the metrological characteristics of the type of instrument;
— measures required for ensuring the integrity of the instruments (sealing, identification of software, etc.);
— information on other elements necessary for the identification of the instruments and to check their visual external conformity to type;
— if appropriate, any specific information necessary to verify the characteristics of manufactured instruments.

The type examination certificate shall have a validity of 10 years from the date of its issue, and may be renewed for subsequent periods of 10 years each.

Where the type does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7. The approved body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

8. The manufacturer shall inform the approved body that holds the technical documentation relating to the type examination certificate of all modifications to the approved type that may affect the conformity of the instrument with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original type examination certificate.

9. Each approved body shall inform the Secretary of State concerning the type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.

The other approved bodies and the Secretary of State may, on request, obtain a copy of the type examination certificates and/or additions thereto. On request, the Secretary of State may obtain a copy of the technical documentation and the results of the examinations carried out by the approved body.

The approved body shall keep a copy of the 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.

10. The manufacturer shall keep a copy of the type examination certificate, its annexes and additions together with the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

11. The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 8 and 10, provided that they are specified in the mandate.

MODULE D:E+W+SCONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2. The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance as specified in paragraph 4.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

(b)a written declaration that the same application has not been lodged with any other approved body,

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the type examination certificate.

3.2. The quality system shall ensure that the regulated measuring instruments are in conformity with the type described in the type examination certificate and comply with the requirements of these Regulations that apply to them.

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. This 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:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

(d)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3. The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

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 designated 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 these Regulations. The audit shall include an assessment visit to the manufacturer's premises.

The auditing team shall review the technical documentation referred to in paragraph 3.1(e), to verify the manufacturer's ability to identify the relevant requirements of these Regulations 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.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system.

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2. The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

4.3. The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4. In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the UK marking and the M marking set out in these Regulations and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual regulated measuring instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations.

5.2. The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities:

(a)the documentation referred to in paragraph 3.1,

(b)the information relating to the change referred to in paragraph 3.5, as approved;

(c)the decisions and reports from the approved body referred to in paragraphs 3.5, 4.3 and 4.4.

7. Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Authorised representative

8. The manufacturer's obligations set out in paragraphs 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

MODULE D1:E+W+SQUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

3. The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

Manufacturing

4. The manufacturer shall operate an approved quality system for production, final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5.1. The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the measuring instruments concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation referred to in paragraph 2.

5.2. The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during, and after manufacture, and the frequency with which they will be carried out;

(d)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

5.3. The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 5.2.

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 designated standard.

The auditing team shall review the technical documentation referred to in paragraph 2 in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations 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.

5.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5. The manufacturer shall keep the approved body that has approved the quality system informed of any intended change of the quality system.

The approved body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 5.2 or whether a re-assessment is necessary.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

6.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6.2. The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

(a)the quality system documentation;

(b)the technical documentation referred to in paragraph 2;

(c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

6.3. The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

6.4. In addition, the approved body may pay unexpected visits to the manufacturer. During such visits the approved body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Conformity marking and declaration of conformity

7.1. The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 5.1, the latter's identification number to each individual regulated measuring instrument that satisfies the applicable requirements of these Regulations.

7.2. The manufacturer shall draw up a written declaration of conformity for each instrument model and keep it at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market. The declaration of conformity shall identify the instrument model for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

8. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities:

(a)the documentation referred to in paragraph 5.1;

(b)the information relating to the change referred to in paragraph 5.5, as approved;

(c)the decisions and reports of the approved body referred to in paragraphs 5.5, 6.3 and 6.4.

9. Each approved body shall inform the Secretary of State of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

Authorised representative

10. The manufacturer's obligations set out in paragraphs 3, 5.1, 5.5, 7 and 8 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

MODULE E:E+W+SCONFORMITY TO TYPE BASED ON INSTRUMENT QUALITY ASSURANCE

1. Conformity to type based on instrument quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned are in conformity with the type described in the type examination certificate and satisfy the requirements of these Regulations that apply to them.

Manufacturing

2. The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 3 and shall be subject to surveillance, as specified in paragraph 4.

Quality system

3.1. The manufacturer shall lodge an application for assessment of his quality system with an approved body of his choice, for the regulated measuring instruments concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the type examination certificate.

3.2. The quality system shall ensure compliance of the regulated measuring instruments with the type described in the type examination certificate and with the applicable requirements of these Regulations.

It shall, in particular, contain an adequate description of:

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the examinations and tests that will be carried out after manufacture;

(c)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned;

(d)the means of monitoring the effective operation of the quality system.

3.3. The approved body shall assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

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 designated standard.

The auditing team shall review the technical documentation referred to in paragraph 3.1(e), in order to verify the manufacturer's ability to identify the relevant requirements of these Regulations 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 audit and the reasoned assessment decision.

3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5. The manufacturer shall keep the approved body that has approved the quality system informed of any intended change to the quality system.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(a)the quality system documentation;

(b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

4.3. The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

Conformity marking and declaration of conformity

5.1. The manufacturer shall affix the UK marking, the M marking set out in these Regulations, and, under the responsibility of the approved body referred to in paragraph 3.1, the latter's identification number to each individual instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of these Regulations.

A copy of the declaration of conformity shall be made available to the market surveillance authorities upon request.

6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities:

(a)the documentation referred to in paragraph 3.1;

(c)the information relating to the change referred to in paragraph 3.5, as approved;

(c)the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4.

Authorised representative

MODULE E1:E+W+SQUALITY ASSURANCE OF FINAL INSTRUMENT INSPECTION AND TESTING

1. Quality assurance of final instrument inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on his sole responsibility that the regulated measuring instruments concerned satisfy the requirements of these Regulations that apply to them.

Technical documentation

3. The manufacturer shall keep the technical documentation at the disposal of the market surveillance authorities for 10 years after the instrument has been placed on the market.

Manufacturing

4. The manufacturer shall operate an approved quality system for final product inspection and testing of the regulated measuring instruments concerned as specified in paragraph 5 and shall be subject to surveillance as specified in paragraph 6.

Quality system

5.1. The manufacturer shall lodge an application for assessment of his quality system with the approved body of his choice, for the regulated measuring instruments concerned.

The application shall include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the instrument category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation referred to in paragraph 2.

5.2. The quality system shall ensure compliance of the regulated measuring instruments with the requirements of these Regulations that apply to them.

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.