In the European Union, pressure equipment and gas appliances typically fall under the scope of three different laws: Pressure Equipment Directive, Simple Pressure Vessels Directive, and Aerosol Dispensers Directive. Both EU and non-EU manufacturers must comply with the applicable Directive if they want to sell their products in the EU market. The Pressure Equipment Directive covers design, manufacture, and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure PS greater than 0,5 bar. This includes products such as vessels, piping, safety accessories and pressure accessories, and also, where applicable, elements attached to pressurised parts, such as flanges, nozzles, couplings supports, and lifting lugs.
Safety requirements for pressure equipment
Annex I of the Pressure Equipment Directive (PED) defines the safety requirements of products falling under this legislation scope. Overall, products must be safe for use in accordance with the manufacturer’s instructions or in reasonably predictable conditions. Moreover, the manufacturer needs to determine whether their products require the involvement of a notified body to assess the conformity. Notified bodies are third-parties assessment entities whose verification is mandatory for a wide range of products in the EU. This requirement applies to both EU and non-EU manufacturer.
Involvement of a notified body for pressure equipment
Based on the risk category, the involvement of a third-party conformity assessment body (notified body) might be necessary. For pressure equipment of Category I, the manufacturer will be subject to internal production control plus supervised pressure equipment checks at random intervals. On the contrary, products of Categories II, III and IV will require the involvement of a notified body. The higher the risk-hazard related to that product is, the more demanding the conformity assessment route will be.
Documentation for a compliant file
In both cases, the manufacturer must draw up a Declaration of Conformity. Moreover, the products must have technical documentation with relevant information to assess that the products are compliant with the applicable laws. Overall, the technical documentation must include:
- A general description of the equipment
- Conceptual design, manufacturing drawings and components’ diagrams, circuits, etc.
- Description for understanding of these drawings
- Design calculations’ results, examinations, etc.
- Test reports.
Following the application of the correct conformity assessment path, the manufacturer can affix the CE Marking.
Authorised Representative for pressure equipment
Whether or not the manufacturer is based in the EU, it is possible to appoint an authorised representative which on behalf of the manufacturer:
- Can apply for the conformity assessment procedure.
- Informs the notified body of any of all modifications to the approved design that can impact the pressure equipment conformity.
- Keeps a copy of the conformity certificate, design type, and technical documentation at disposal of competent authority for 10 years.
Finally, products falling under the Pressure Equipment Directive are covered by the Market Surveillance Regulation as well. This implies that non-EU manufacturers must have at least one economic operator based in the EU.
If you want to know more about the regulatory requirements to sell pressure equipment in the EU, contact us today and register for free on PRODlaw.
References:
EUR-Lex (2019) Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011. Retrieved on 09/05/2023.
EUR-Lex (2014) Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment. Retrieved on 09/05/2023.
European Commission. (2023). NANDO: 2014/68/EU Pressure equipment. Retrieved on 10/05/2023.
European Commission (2023) Manufacturers. Retrieved on 09/05/2023.
Obelis (2023) What is CE Marking?. Retrieved on 09/05/2023.
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