Medical Device Regulation (EU) 2017/745 (MDR)
October 1, 2026
REACH Regulation (EC) No 1907/2006
October 1, 2026
The ATEX Directive 2014/34/EU sets the essential health and safety requirements and the conformity assessment procedures for equipment and protective systems intended for use in potentially explosive atmospheres. It replaced Directive 94/9/EC. Products in scope carry the CE marking and the specific explosion protection marking on the EU and the Turkish market.
For ATEX conformity and CE marking of your product, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.
What is an explosive atmosphere?
It is a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture. Typical flammable gases are methane, propane, butane, hexane, ethylene, hydrogen and acetylene.
Such atmospheres occur in refineries and fuel depots, chemical plants and laboratories, mines, gas pressure stations, and plants handling paint, food, pharmaceutical or wood dust.
Two sets of rules
| Legislation | Addressed to | Subject |
|---|---|---|
| Directive 2014/34/EU | Manufacturers, importers, distributors | Design and placing on the market of equipment and protective systems |
| Directive 1999/92/EC | Employers | Protection of workers: risk assessment, classification of workplaces into zones, explosion protection document |
Zones
| Gas, vapour, mist | Dust | Explosive atmosphere is present |
|---|---|---|
| Zone 0 | Zone 20 | Continuously, for long periods or frequently |
| Zone 1 | Zone 21 | Likely to occur occasionally in normal operation |
| Zone 2 | Zone 22 | Not likely in normal operation and, if it occurs, only for a short period |
Products covered by 2014/34/EU
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Safety devices, controlling devices and regulating devices intended for use outside such atmospheres but required for the safe functioning of equipment and protective systems with respect to explosion risks
- Components intended to be incorporated into equipment and protective systems
Excluded are:
- Medical devices intended for use in a medical environment
- Equipment where the explosion hazard results exclusively from explosive or unstable chemical substances
- Equipment for domestic and non-commercial environments where an explosive atmosphere is rarely created, and only by an accidental leak of fuel gas
- Personal protective equipment
- Seagoing vessels and mobile offshore units with their on-board equipment
- Means of transport, except vehicles intended for use in a potentially explosive atmosphere
- Military equipment
Groups, categories and conformity assessment
| Equipment | Use | Procedure |
|---|---|---|
| Group I, category M1; Group II, category 1 | Mines; Zone 0 or 20 | EU-type examination by a notified body, plus production quality assurance or product verification |
| Group I, category M2; Group II, category 2: electrical equipment and internal combustion engines | Mines; Zone 1 or 21 | EU-type examination by a notified body, plus conformity to type or product quality assurance |
| Group II, category 2: other (non-electrical) equipment | Zone 1 or 21 | Internal production control, with the technical documentation lodged with a notified body |
| Group II, category 3 | Zone 2 or 22 | Internal production control by the manufacturer |
Unit verification by a notified body is an alternative for any category. Components are supplied with a written attestation of conformity and do not carry the CE marking.
Duties of each operator
- Manufacturer: designs and manufactures to the essential requirements, draws up the technical documentation, carries out the conformity assessment, issues the EU Declaration of Conformity and affixes the markings. Keeps the documents for 10 years.
- Authorised representative: acts under a written mandate, which cannot include drawing up the technical documentation. Keeps the declaration and the documentation for 10 years.
- Importer: places only compliant products on the market and makes sure the manufacturer has carried out the conformity assessment.
- Distributor: verifies the CE marking, the declaration or attestation and the instructions before making the product available.
Marking
The CE marking is affixed visibly, legibly and indelibly to the product or its data plate. It is followed by the identification number of the notified body involved in the production control phase, the specific explosion protection marking (the Ex symbol in a hexagon), and the symbols of the equipment group and category, with G for gas or D for dust for Group II.
ATEX and other legislation
- Low voltage: electrical equipment for explosive atmospheres is excluded from the Low Voltage Directive; its electrical safety is assessed under ATEX.
- Machinery: a machine for use in an explosive atmosphere is subject to both; see machinery CE marking.
- EMC and RoHS: electronic Ex equipment also falls under EMC and RoHS requirements.
ATEX in Turkey
Turkey applies the Directive through its own regulation on equipment and protective systems for potentially explosive atmospheres, published in the Official Gazette in 2016 and aligned with 2014/34/EU. A separate Turkish regulation, aligned with 1999/92/EC, requires employers to prepare an explosion protection document.
