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Procedure for Application, Issue, Amendment, Revocation and Renewal of National Type Approval Certificates and for Legal Metrological Expert Assessment of Measuring Instruments

Passed 20.12.2018 No. 66

The Regulation is established pursuant to subsection 8 (9) of the Metrology Act.

Chapter 1 General Provisions 

§ 1.  Scope of application

 (1) Chapter 2 of this Regulation shall be applied to the measuring instruments specified in clause 6 (3) 4) of the Metrology Act.

 (2) Chapter 3 of this Regulation shall be applied to the cases where a measuring instrument is declared to have passed verification as provided for in subsection 10 (3) of the Metrology Act.

Chapter 2 Procedure for National Type Approval Certificate 

§ 2.  Applying for national type approval certificate

 (1) The manufacturer of a measuring instrument, its authorised representative, supplier or possessor of a measuring instrument (hereinafter applicant) shall submit an application for the issue, amendment or renewal of the national type approval certificate of a measuring instrument to the Consumer Protection and Technical Regulatory Authority (hereinafter type approval certificate) to which the following documents shall be appended:
 1) authorisation issued to the applicant to represent the manufacturer of the measuring instrument;
 2) the document certifying compliance as provided for in subsection 8 (4) of the Metrology Act;
 3) technical description of the measuring instrument;
 4) installation instructions or instructions for use of the measuring instrument;
 5) drawings or schemes describing the places where the verification marks are attached onto the measuring instrument;
 6) other relevant documents containing data on the type of the measuring instrument.

 (2) In case of applying for a type approval certificate or amendment of a type approval certificate for a measuring instrument which has been brought to Estonia as a part of complete equipment or fittings, the applicant may choose not to submit the document specified in clause (1) 1).

 (3) The Consumer Protection and Technical Regulatory Authority shall inform the applicant about the need to send the measuring instrument for additional testing or calibration and about an appropriate accredited laboratory.

§ 3.  Legal metrological expert assessment for type approval of measuring instrument

 (1) In the course of legal metrological expert assessment, the Consumer Protection and Technical Regulatory Authority compares the documents and test reports submitted, assesses the compliance of the measuring instrument type with the metrological and technical requirements established by legislation and in the relevant technical specification, and decides on the issue, amendment or renewal of the type approval certificate.

 (2) The Consumer Protection and Technical Supervisory Authority may send a measuring instrument for additional testing or calibration, and send the documents submitted by the applicant to a testing or calibration laboratory in a manner coordinated with the applicant, appending a list of the necessary tests or measurements (hereinafter tests).

 (3) In the case specified in subsection (2), the applicant shall submit the measuring instrument to the testing or calibration laboratory.

 (4) The testing or calibration laboratory shall return the original documents which were submitted to the laboratory to the Consumer Protection and Technical Regulatory Authority after completion of the tests, appending the test or calibration protocols and the test report or calibration certificate prepared on the basis of the protocols.

 (5) As a result of the legal metrological expert assessment, the Consumer Protection and Technical Regulatory Authority shall issue a type approval certificate for the measuring instrument to the applicant, or amend or renew it provided that the measuring instrument complies with the requirements set out in the regulation established pursuant to subsection 6 (4) of the Metrology Act and in subsection 8 (3) of the Metrology Act. If the measuring instrument does not comply with said requirements, the Consumer Protection and Technical Regulatory Authority shall issue a decision to the applicant, providing the reason for refusal to issue, amend or renew the type approval certificate.

 (6) The Consumer Protection and Technical Regulatory Authority shall decide on the issue, amendment or renewal of a type approval certificate within 21 days after receipt of the documents set out in subsection 2 (1).

§ 4.  Type approval certificate

 (1) The type approval certificate must contain at least the following data:
 1) name and address of the Consumer Protection and Technical Regulatory Authority;
 2) name and address of the applicant for the type approval certificate;
 3) reference to the Metrology Act, the regulation established pursuant to subsection 6 (4) of the Metrology Act, and this Regulation;
 4) reference to the relevant standard or a document of the International Organization of Legal Metrology (OIML) or other technical specification;
 5) name of the manufacturer and type of the measuring instrument;
 6) type approval mark;
 7) date of issue and validity period of the type approval certificate.

 (2) The shape, items and ratios describing the measurements of a type approval mark are set out in the Annex to this Regulation.

 (3) Where necessary, the Consumer Protection and Technical Regulatory Authority shall provide the applicant with an appendix to the type approval certificate which must contain the following data:
 1) names of the measuring instrument type models;
 2) list of components and supporting documents of a measuring instrument set;
 3) short characterisation of the metrological properties, purpose of use, marks, installation requirements and function of the measuring instrument;
 4) instructions for attaching the verification marks.

 (4) A type approval certificate shall be valid only for the measuring instrument type indicated, and for the models, if any, listed in the certificate.

§ 5.  Amendment of type approval certificate on initiative of Authority

  The Consumer Protection and Technical Regulatory Authority may, on its own initiative, amend a type approval certificate if an error appears in the given type approval certificate, by notifying the person who applied for the type approval certificate about its intention and the contents of the amendment, and providing the opportunity to submit explanations within 30 days.

§ 6.  Revocation of type approval certificate

  The revocation of a type approval certificate shall be drawn up as a reasoned decision in the cases set out in subsection 8 (7) of the Metrology Act.

Chapter 3 Declaring Measuring Instrument to have Passed Verification 

§ 7.  Applying for declaring measuring instrument to have passed verification

  The bearer of the measuring instrument verification obligation shall submit an application to the Consumer Protection and Technical Regulatory Authority together with a traceable measurement result of the measuring instrument set out in:
 1) test certificate of an accredited testing laboratory;
 2) calibration certificate of an accredited calibration laboratory, or
 3) verification protocol or certificate of a competent metrology authority.

§ 8.  Legal metrological expert assessment in declaring measuring instruments to have passed verification

 (1) The Consumer Protection and Technical Regulatory Authority inspects the following in the course of the legal metrological expert assessment:
 1) compliance of the measuring instrument and measuring result with the requirements of the Regulation established pursuant to subsection 6 (4) of the Metrology Act;
 2) absence of verification possibilities in Estonia;
 3) existence of an EC or Estonian type approval certificate or passing of conformity assessment;
 4) compliance of submitted documents with § 7.

 (2) The Consumer Protection and Technical Regulatory Authority marks a measuring instrument with a verification mark if it is required in the type approval of the measuring instrument. Measuring instruments verified by a competent metrology authority are not marked with a verification mark.

 (3) The Consumer Protection and Technical Regulatory Authority decides on declaring a measuring instrument to have passed verification within 14 days after receipt of the documents set out in § 7.

Chapter 4 Entry into Force 

§ 9.  Entry into force of Regulation

  This Regulation enters into force on 1 January 2019.

Annex The shape and ratios describing the measurements of type approval mark of measuring instrument, and items on the mark