Contact person
Josefin Damberg
TIC-ingenjör
Contact JosefinEquipment and safety systems for explosive environments must be CE marked and, in some cases, EX marked in accordance with Directive 2014/34/EU. RISE is a notified body that assesses various equipment and safety systems and can issue the documents that the manufacturer needs for CE and EX marking.
The purpose of an EU type certificate for equipment or protective systems is to allow the product to be placed on the European market.
It is the manufacturer's responsibility to ensure that the equipment or protective system meets the requirements of the directive and is CE marked and EX marked. The manufacturer is considered to be the one who places the equipment or protective system on the market in their name, regardless of whether they have manufactured the equipment or protective system themselves or had someone else manufacture it on their behalf.
The manufacturer must engage a notified body to review the equipment or protective system and assess whether it complies with the directive's requirements. If the notified body concludes that the equipment or protective system meets the requirements, an EU type certificate (EU-type examination certificate), Unit verification certificate, Conformity of type notification, Certificate of conformity, Product quality assurance notification, or Production quality assurance notification is issued, which the manufacturer can use as part of the basis required to CE mark the measuring instrument.
For many of the equipment or protective systems, harmonized standards have been developed. If the equipment or protective system is designed entirely according to such a standard, it automatically shows that it meets the applicable requirements of the directive. In cases where a harmonized standard is not followed, the manufacturer must demonstrate how the applicable requirements of the directive are met during the intended use of the measuring instrument. RISE develops an evaluation plan to verify that the requirements are relevant and met.
The process starts with the manufacturer submitting an application to RISE for the review of the equipment or protective system. A technical dossier is attached to the application. A special application form is available, which also describes what should be included in the technical dossier. If the equipment is designed according to a harmonized standard, this is used as the basis for testing and evaluation. The technical dossier and the results of the tests are evaluated.
In cases where a harmonized standard is not available or not followed, the manufacturer must describe how the relevant essential requirements of the directive are met in the application. The description must also explain how the solutions achieved were arrived at. An evaluation plan is developed by RISE in consultation with the manufacturer to test the equipment.
If RISE assesses that the product meets the requirements, a certificate* is issued.
* EU type certificate, Conformity to Type Notification, Assessment Decision Production Quality Assurance Notification, Product Quality Assurance Notification, Certificate of Conformity, or Unit Verification Certificate is issued.
According to the ATEX directive 2017/32/EU, Article 13, paragraph 1, point (b) (ii), technical documentation for products in category 2 equipment (2G and 2E) must be archived with a Notified Body. After receiving the application and technical documentation, RISE archives the technical documentation for 10 years.
Link to European Commission webpage for Equipment and protective systems intended for use in potentially explosive atmospheres, ATEX:
Equipment for potentially explosive atmospheres (ATEX) - European Commission (europa.eu)