CE marking of measuring instruments, MID

Purpose

It is the manufacturer's responsibility to ensure that the measuring instrument meets the requirements of the directive and that it is CE marked. The term manufacturer means any natural or legal person who places the measuring instrument on the market, under his name or trademark, no matter if he has manufactured the measuring instrument by himself, or has had parts of or all manufacturing made by another company. 

The manufacturer must turn to a Notified Body with an application for assessment. The task of the Notified Body is to review the measuring instrument and determine whether the instrument complies to the requirements of the directive. If the Notified body concludes that the measuring instrument meets the requirements, an EU type examination certificate, assessment decision or certificate of conformity will be issued, which the manufacturer can use as part of the documentation required for CE marking. 

For some of the measuring instruments, harmonized standards have been developed and are applicable. If the measuring instrument in full comply with a harmonized standard, the requirements of the directive will automatically be met. In cases where a harmonized standard is not applicable, the manufacturer must show how the essential requirements of the directive have been met for the intended use of the instrument. RISE performs an evaluation to verify that the solutions are relevant and that the requirements are fulfilled.

Method

• EU type examination (module B)

The process starts when RISE receives an application from the manufacturer for EU type examination of a measuring instrument in accordance with directive 2014/32/EU. The technical documentation shall be attached to the application. A special application form is available, and this also describes what should be included in the technical documentation.

If the instrument is designed according to a harmonized standard, this will be used as a basis for testing and evaluation. The technical documentation and the results of the tests are evaluated.

In cases where a harmonized standard is not applicable or not complied with, the manufacturer is obligated to describe how the measuring instrument complies with the relevant essential requirements, as an attachment to the application. The description shall also describe the solutions used to fulfil the essential requirements. A plan for evaluation is developed by RISE in consultation with the manufacturer, on how to test the equipment.

• Assessment of quality system (module D)

The manufacturer applies to RISE for an assessment of the quality system regarding the manufacture of one or more measuring instruments. The measuring instruments shall have a valid EU / EC type-examination certificate from RISE or any other notified body. The certificates and technical documentation must be attached to the application (not required if RISE has issued the certificates).

RISE, in agreement with the manufacturer, performs an initial assessment of the quality system on site at the manufacturers premises. Follow-up assessment of the quality system then takes place annually.

• Conformity to type based on product verification (module F)

The manufacturer applies to RISE for product verification to verify the compliance of the measuring instrument with the EU/EC type examination certificate. Product verification is carried out by testing each measuring instrument or by statistical checks of a batch of measuring instruments. 

The measuring instruments must have a valid EU/EC type certificate from RISE or another notified body. The EU/EC type examination certificate and declaration of conformity shall be attached to the application. A special application form is available, and this also describes what must be attached to the application.

• ​​Conformity based on unit verification (module G)

The process starts when RISE receives an application from the manufacturer for assessment of a measuring instrument in accordance with directive 2014/32/EU. The technical documentation shall be attached to the application. A special application form is available, and this also describes what should be included in the technical documentation.

If the instrument is designed according to a harmonized standard, this will be used as a basis for testing and evaluation. The technical documentation and the results of the tests are evaluated.

In cases where a harmonized standard is not applicable or not complied with, the manufacturer is obligated to describe how the measuring instrument complies with the relevant essential requirements, as an attachment to the application. The description shall also describe the solutions used to fulfil the essential requirements. A plan for evaluation is developed by RISE in consultation with the manufacturer, on how to test the equipment.

• Conformity based on full quality assurance (module H)

The process starts when the manufacturer applies to RISE for an assessment of the quality system regarding the manufacture of one or more measuring instruments. The technical documentation shall be attached to the application. A special application form is available, and this also describes what should be included in the technical documentation.

RISE, in agreement with the manufacturer, performs an initial assessment of the quality system on site at the manufacturers premises.

Deliveries

• EU type examination (module B)

If RISE makes the assessment that the measuring instrument meets the requirements, an EU type examination certificate will be issued. The validity period for a certificate is 10 years, and requires, among other things, that no changes will be made to the instrument, that the harmonized standard is still harmonized or, in the case where the harmonized standard has not been applied, that new knowledge or experiences does not dispute the original assessment.

• Assessment of quality systems (module D)

RISE reports the result from the initial assessment in a written report. Any deviations shall be corrected by the manufacturer and reported to RISE. Once RISE has approved the measures, an assessment decision is issued regarding the production control. The validity period for an assessment decision is 5 years. This gives the manufacturer the right to use RISE id no. as Notified Body together with the CE marking on the measuring instrument(s) concerned. Follow-up audits of the quality system must then be carried out at 1-year intervals.

• Conformity to type based on product verification (module F)

If RISE makes the assessment that the measuring instrument(s) meets the requirements, RISE will issue a certificate of conformity. The certificate has no validity period. The certificate gives the manufacturer the right to use the RISE id no. as Notified Body together with the CE marking on the measuring instrument(s) covered by the certificate.

• ​​Conformity based on unit verification (module G)

If RISE makes the assessment that the measuring instrument meets the requirements, RISE will issue a certificate of conformity. The certificate has no validity period. The certificate gives the manufacturer the right to use the RISE id no. as Notified Body together with the CE marking on the measuring instrument covered by the certificate.

• Conformity based on full quality assurance (module H)

RISE reports the result from the initial assessment in a written report. Any deviations shall be corrected by the manufacturer and reported to RISE. Once RISE has approved the measures, an assessment decision is issued regarding the production control. The validity period for an assessment decision for module H is 3 years.

This gives the manufacturer the right to use RISE id no. as Notified Body together with the CE marking on the measuring instrument concerned. Follow-up audits of the quality system must then be carried out at 1-year intervals.

Mer information