CE marking of non-automatic weighing instruments, NAWI

Purpose

The purpose of an assessment of a non-automatic weighing instrument is to give the manufacturer the documents necessary to place the non-automatic weighing instrument on the European market.

It is the manufacturer's responsibility to ensure that the non-automatic weighing 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 non-automatic weighing instrument on the market, under his name or trademark, no matter if he has manufactured the non-automatic weighing 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 non-automatic weighing instrument and determine whether the instrument complies to the requirements of the directive. If the Notified Body concludes that the non-automatic weighing 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 non-automatic weighing instruments, harmonized standards have been developed and are applicable. If the non-automatic weighing 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.

Non-automatic weighing instruments according to directive 2014/31/EU, chapter 1, article 1, point 2 are instruments for one or more of the following purposes:

1. Determination of mass for commercial transactions.
2. Determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment.
3. Determination of mass for the application of laws or regulations or for an expert opinion given in court.
4. Determination of mass in the practice of medicine for weighing patients for the purposes of monitoring, diagnosis and medical treatment.
5. Determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories.
6. Determination of price on the basis of mass for the purposes of direct sales to the public and the making-up of prepackages.
7. All applications other than those listed in points (a) to (f).

Method

• EU type examination (module B)

The process starts when RISE receives an application from the manufacturer for EU type examination of a non-automatic weighing instrument in accordance with directive 2014/31/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 non-automatic weighing 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 non-automatic weighing instruments. The non-automatic weighing 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 non-automatic weighing instrument with the EU/EC type examination certificate. Product verification is carried out by testing each non-automatic weighing instrument or by statistical checks of a batch of non-automatic weighing instruments. 

The non-automatic weighing 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.

Deliveries

• EU type examination (module B)

If RISE makes the assessment that the non-automatic weighing 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 3 years. This gives the manufacturer the right to use RISE id no. as Notified Body together with the CE marking on the non-automatic weighing 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 non-automatic weighing 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 non-automatic weighing instrument(s) covered by the certificate.

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