The Measurement Instruments Directive 2014/32/EU, what is it and how does it impact your business? How is it related to CE marking and EU product certification rules? In this Guide to the Measurement Instruments Directive, you will find the answers to these questions and more. You will learn what the objectives of the Measurement Instruments Directive are, what products are covered, and how to achieve CE certification for your products.
Table of Contents
Short name: Measurement Instruments Directive or Measuring Instrument Directive
Reference Number: 2014/32/EU
Official Title: Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments
Measurement Instruments Directive 2014/32/EU lays down uniform, EU-wide rules on the sale and putting into use of measuring instruments. Measuring instruments are important for trade, consumers and industry as they ensure the accuracy of measurements and help the transparency and fairness of commercial transactions.
The directive aims to:
- establish the essential requirements that instruments or systems with a measurement function have to satisfy;
- introduce simpler, clearer and more-consistent rules and ensure traceability;
- reduce administrative burdens for manufacturers, importers and distributors;
- ensure that instruments compliant with the essential requirements can circulate freely within the EU.
- compliant and more-accurate measuring instruments on the EU market and increased levels of public trust in them;
- fewer non-compliant instruments and distortions of competition on the market arising from different enforcement practices;
- protection of the public from wrong measurements;
- increased room for technological innovation, by adopting a modern regulatory approach.
Directive 2014/32/EU is applicable since 20 April 2016. It replaces Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments.
Frequently asked questions about the Measurement Instruments Directive 2014/32/EU
Which products are covered by the Measurement Instruments Directive 2014/32/EU?
This Directive applies to the following products:
– utility meters (water meters, gas meters and volume-conversion devices, active electrical – energy meters and thermal energy meters);
– measuring systems for the continuous and dynamic measurement of quantities of liquids other than water (e.g. petrol pumps);
– automatic weighing instruments (e.g. rail weigh-bridges or automatic packaging lines);
– material measures and dimensional measuring instruments (e.g. for metalworking or woodworking); and
– exhaust gas analysers (e.g. to check engine performance).
The Directive 2014/32/EU applies to all measuring instruments that are new to the EU market when they are placed on that market or put into use, that is that they are:
a) new measuring instruments made by a manufacturer established in the EU; or
b) imported from a non-EU country, whether they are new or second hand.
Which products are exempted from the Measurement Instruments Directive 2014/32/EU?
The Directive does not apply to any measuring instruments not specifically mentioned in article 2, paragraph 1 of the Directive. The measuring instruments included in the scope are mentioned above.
Examples of products that are not included in the scope of the Directive 2014/32/EU:
– Measuring containers
– Level indicators
– Material measures of capacity for liquids
– Material measures of capacity for grain
– Moisture content meters for cereal grain and oleaginous grain
– Bulk milk cooler tanks
– Alcoholometers and hydrometers for alcohol and alcoholometric tables
– Radar speed detectors
– Manometers used for inflation of vehicle tyres
– Automatic saccharimeters for sugar beet delivered to refineries and distilleries
– Refractometers for measuring sugar content of grape must
– Instruments for measuring opacity of emissions from diesel engine vehicles
– Sound level meters
What is the conformity assessment procedure for the Measuring Instruments Directive 2014/32/EU?
The conformity assessment for a measuring instrument requires the involvement of a third party certification body, also called a ‘notified body’. For this directive, CE self-certification is not allowed. The notified body conducts a ‘type-examination’ and ensures the manufacturing processes result in consistent quality outputs.
How to comply with the Measurement Instruments Directive 2014/32/EU:
Manufacturers must ensure that:
- all measuring instruments on sale in the EU bear the conformity marking consisting of the European conformity (CE) marking plus the supplementary metrology (M) marking, with the last two digits of the year of its affixing and the notified body number(s), indicating that they meet all the essential requirements of EU legislation (set out in Annex I of the directive and in the relevant instrument-specific annexes);
- they conduct a risk and conformity assessment and draw up technical documentation for the MI before affixing the CE + M markings (see Annex II of the directive);
- they (and if they appoint an authorised representative*) keep the technical documentation and the EU declaration of conformity (as set out in Annex II of the directive) for 10 years after the measuring instrument has been placed on the market;
- they indicate on the measuring instrument their name, registered trade name or registered trade mark and the postal address where they can be contacted to ensure traceability;
- in the event they believe that measuring instrument they have placed on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them;
- instructions and information accompanying the measuring instrument are written in a language easily understood by its end users and that they, as well as any labelling, are clear and understandable.
Importers must ensure that:
- Measuring instruments they place on the market comply with the essential requirements;
- manufacturers have carried out conformity assessments correctly and inform the market surveillance authorityif they consider that the measuring instruments do not comply;
- they indicate on the measuring instrument their name, registered trade name or registered trade mark and the postal address where they can be contacted;
- marking of measuring instruments and documentation drawn up by manufacturers are available for inspection by the competent authorities.
Distributors must ensure that:
- Measuring instruments under their responsibility, or measuring instruments’ storage or transport conditions do not place at risk their compliance with the essential requirements;
- measuring instruments bear the necessary markings;
- in the event they believe that measuring instruments they have made available on the market do not conform, take corrective measures to bring them into conformity, withdraw or recall them.
Links & Downloads
- Download the Measuring Instruments Directive 2014/32/EU from the Official Journal of the EU
- Link to list of harmonised standards
- Link to guidance documents
- List of notified bodies for the Measuring Instruments Directive 2014/32/EU
Do you need help with CE marking according to the Measurement Instruments Directive 2014/32/EU?
Are you making available measuring instruments covered by the Measuring Instruments Directive in the EU market? In that case, your product may need to comply with the CE rules. Hopefully, this article has provided you with the guidance to get started.
We understand that the requirements and CE certification process are daunting and rather intimidating. Particularly, considering all your efforts may be in vain if you don’t get the required steps right. We will be happy to help. We offer consulting and coaching solutions and can tailor our services to your specific needs.
Reach out to us by phone, or simply fill out the form below to ensure we have the information we need to provide you with a fitting offer. Our team looks forward to assisting you.
Other articles that may be of interest
- What is CE marking?
- What does the CE mark mean? What do the initials CE stand for?
- Do your products need CE marking?
- How do you benefit from CE marking??
- In which countries is the CE marking required?
- What does CE certification cost?
- Do our products automatically qualify for the CE mark when they are UL/CSA approved?
- Who should undertake CE marking?
- Notified Bodies: What are they, and what is their role?
- What is the CE marking process?
- What files / documentation must I keep?
- How and where must the CE mark appear?
- Other Posts About CE Marking
Other CE Directives and Regulations that may be of interest
- Machinery Directive
- Low Voltage Directive
- EMC Directive
- Medical Devices Regulation
- Personal Protective Equipment Regulation
- Construction Products Regulation 305/2011
- Pressure Equipment Directive
- REACH Regulation
- Restriction of Hazardous Substances Directive (RoHS)
- ATEX Directive
- Toys Safety Directive (2009/48/EC)
- Radio Equipment Directive
- Recreational Craft and Personal Watercraft Directive
- Active Implantable Medical Devices Directive
- Explosive for Civil Use (CIVEX) Directive
- Noise Emission Directive
- Gas Appliances Directive 2009/142/EEC
- Lifts Directive 1995/16/EC
- Pyrotechnic Directive 2013/29/EU
- Measuring Instruments Directive