PED & PESR Compliance Support
Pressure Equipment Directive | Pressure Equipment (Safety) Regulations 2016
Pressure equipment legislation is widely misunderstood — even by experienced fabricators and design houses who have been manufacturing pressure equipment for years. The consequences of getting it wrong range from failed audits and rejected documentation to product liability, enforcement action, and equipment that cannot legally be placed on the market.
GC Logicals provides practical, plain-English compliance support for fabricators and design houses navigating PED and PESR — from initial assessment through to final conformity.
PED and PESR — What Are They and What Is the Difference?
PED — Pressure Equipment Directive (2014/68/EU)
The Pressure Equipment Directive is European Union legislation governing the design, manufacture, and conformity assessment of pressure equipment and assemblies. It applies to pressure equipment placed on the EU market. If you are manufacturing for European clients or supplying into the EU, PED applies.
PESR — Pressure Equipment (Safety) Regulations 2016
Following the UK’s departure from the European Union, the PESR became the retained UK equivalent of the PED. The PESR governs pressure equipment placed on the UK market. In practice the technical requirements are broadly aligned with PED — but the conformity assessment routes, approved body designations, and marking requirements differ.
The Key Practical Difference
- Equipment placed on the EU market requires CE marking under PED and assessment by an EU Notified Body
- Equipment placed on the UK market requires UKCA marking under PESR and assessment by a UK Approved Body
- Equipment supplied into both markets may require both — this is an increasingly common challenge for UK fabricators and design houses exporting to Europe
If you are unsure which legislation applies to your product, that question needs to be answered before design commences — not after manufacture is complete.
DOES IT APPLY TO YOU?
PED and PESR apply to pressure equipment and assemblies where the maximum allowable pressure (PS) exceeds 0.5 bar. This covers a very wide range of equipment including:
- Pressure vessels
- Piping and pipework assemblies
- Safety accessories
- Pressure accessories (valves, fittings, flanges)
- Steam generators
Exclusions include — amongst others — pipelines for gas, oil, and water supply; equipment specifically covered by other directives; and nuclear equipment covered by Euratom. The exclusions list is specific and should not be assumed. If you believe your equipment may be excluded, take advice.
Sound Engineering Practice (SEP) — Inside or Outside PED/PESR?
This is one of the most frequently misunderstood areas of pressure equipment legislation — and misunderstanding it carries risk in both directions.
What is SEP?
Sound Engineering Practice applies to pressure equipment that falls below the threshold for categorisation under PED/PESR — typically low pressure, low hazard equipment where the risk does not justify formal conformity assessment. Article 4(3) of PED (and the equivalent PESR provision) permits this equipment to be designed and manufactured to Sound Engineering Practice rather than through a formal conformity assessment module.
What SEP Does Not Mean
SEP is not a deregulated space. Equipment manufactured to SEP:
- Must still be safe and fit for purpose
- Must still be designed by competent persons
- Must still be accompanied by adequate instructions
- Does not carry CE or UKCA marking
- Does not require a Declaration of Conformity
The Common Mistake
Many fabricators assume that if equipment is SEP it requires no documentation and no formal process. This is incorrect. If a SEP item causes harm, the manufacturer must still demonstrate that it was designed and built to an appropriate standard. The absence of a formal module does not remove the obligation to demonstrate competence and control.
Is My Equipment SEP?
This depends on fluid group, maximum allowable pressure, volume or nominal size, and equipment type. The categorisation tables in PED Annex II (and the equivalent PESR Schedule) determine whether equipment falls into Category I, II, III, IV — or below the threshold into SEP territory. GC Logicals can carry out this assessment for you.
Categories — What Are They and Why Do They Matter?
PED and PESR classify pressure equipment into four categories based on the level of hazard presented — determined by a combination of:
- Fluid Group — Group 1 (dangerous fluids: flammable, toxic, oxidising) or Group 2 (all other fluids including steam and hot water)
- Maximum Allowable Pressure (PS) in bar
- Volume (V) in litres for vessels, or Nominal Size (DN) for piping
Category I — Lowest hazard. Least onerous conformity assessment route available.
Category II — Moderate hazard. More rigorous assessment required.
Category III — Significant hazard. Third party involvement mandatory in most cases.
Category IV — Highest hazard. Most stringent conformity assessment route required. Full Notified/Approved Body involvement mandatory.
Why Category Matters
The category your equipment falls into determines:
- Which conformity assessment modules are available to you
- Whether you need a Notified or Approved Body at all
- What technical documentation you must produce and retain
- What marking and declaration you must issue
Getting the category wrong — in either direction — is a serious compliance failure. Under-categorising equipment is the more dangerous error and carries significant liability.
Conformity Assessment Modules — What Are They?
The module system defines the route you take to demonstrate that your equipment conforms to the Essential Safety Requirements. Different modules are available depending on category, and some require third party involvement while others do not.
Suggested layout: table or card block — one card per module
Module A — Internal Production Control
The manufacturer takes full responsibility for design and manufacture against the Essential Safety Requirements. No third party involvement required. Available for Category I only. The manufacturer holds a Technical File and issues a Declaration of Conformity.
Module A2 — Internal Production Control with Supervised Vessel Testing
As Module A but with supervised testing of finished vessels by a third party. Available for certain Category II equipment.
Module B — EU/UK Type Examination
A Notified or Approved Body examines the design and issues a Type Examination Certificate confirming it meets the Essential Safety Requirements. Module B is always used in combination with a production module (B+C2, B+D, B+E, B+F).
Module C2 — Conformity to Type Based on Internal Production Control with Supervised Testing
Manufacture conforms to the approved type (Module B). Periodic supervised testing by a third party.
Module D — Conformity to Type Based on Quality Assurance of the Production Process
The manufacturer operates a quality management system approved and surveilled by a Notified or Approved Body covering the production process. Typically requires ISO 9001 as a minimum foundation.
Module D1 — Quality Assurance of the Production Process (without Module B)
Similar to Module D but used without a prior Type Examination. The Notified or Approved Body approves and surveils the full QMS.
Module E — Conformity to Type Based on Product Quality Assurance
QMS covers final inspection and testing rather than the full production process.
Module E1 — Product Quality Assurance (without Module B)
As Module E but without prior Type Examination.
Module F — Conformity to Type Based on Product Verification
Individual product verification by a Notified or Approved Body against the approved type.
Module G — Conformity Based on Unit Verification
Each individual item of equipment is examined and tested by a Notified or Approved Body. Used for Category IV equipment and one-off or small series manufacture where type examination is not practical. The most onerous route.
Module H — Conformity Based on Full Quality Assurance
The manufacturer operates a comprehensive QMS covering design, manufacture, and final inspection — approved and surveilled by a Notified or Approved Body. Used for Category III and IV.
Module H1 — Full Quality Assurance with Design Examination
As Module H but with additional design examination by the Notified or Approved Body. Required for certain Category IV equipment.
Essential Safety Requirements (ESR)
The Essential Safety Requirements are the fundamental technical and safety obligations that all pressure equipment within scope must satisfy. They are set out in Schedule 2 of the PESR and Annex I of PED and cover:
- Design — adequate for the intended service conditions including pressure, temperature, corrosion, fatigue, and external loads
- Manufacturing — appropriate materials, joining processes (including welding), and non-destructive examination
- Materials — suitable for the fluid, temperature, and pressure conditions; accompanied by appropriate material certification
- Welding — welding of pressure-bearing parts must be carried out by qualified personnel using qualified procedures. This is a direct requirement of the ESR — not a choice
- NDT — non-destructive examination of welds and joints to a defined and documented standard
- Pressure Testing — final pressure test to demonstrate integrity before placing on the market
- Marking and Instructions — correct marking (CE or UKCA), Declaration of Conformity, and operating instructions
The ESR are not optional and they are not a checklist. They are legal obligations. Demonstrating compliance with them is the purpose of the entire conformity assessment process.
When Do You Need a Notified or Approved Body?
ou do not need a Notified or Approved Body for:
- SEP equipment
- Category I equipment assessed under Module A
You may need a Notified or Approved Body for:
- Category II equipment depending on the module selected
You must involve a Notified or Approved Body for:
- Category III equipment — in all cases
- Category IV equipment — in all cases
- Any equipment assessed under Modules B, D, D1, E, E1, F, G, H, or H1
A Notified Body operates under EU designation for CE marking under PED.
An Approved Body operates under UK designation for UKCA marking under PESR.
Some bodies hold both designations — particularly important if you are supplying into both markets.
How Do You Demonstrate Full Compliance?
This is where many fabricators and design houses fall short — not because they are building non-compliant equipment, but because they cannot demonstrate that the process was controlled. In pressure equipment legislation, an unrecorded control is no control at all.
A compliant PED/PESR manufacturing process requires:
Design Control
- Design calculations to an appropriate pressure vessel code (PD5500, ASME VIII, EN 13445)
- Design review and approval
- Technical File compiled and retained for a minimum of 10 years
Material Control
- Materials traceable to 3.1 or 3.2 certificates as required
- Material suitability for fluid, temperature, and pressure conditions verified
Welding Control
- Welding Procedure Specifications (WPS) qualified to EN ISO 15614 or ASME IX
- Welders qualified to EN ISO 9606 or ASME IX
- Weld maps demonstrating traceability of every pressure-bearing weld to a qualified welder and procedure
NDT Control
- Written NDT procedures
- Qualified NDT personnel (PCN or ASNT as appropriate)
- NDT reports retained in the Technical File
Pressure Testing
- Written pressure test procedure
- Witnessed and documented test
- Test report retained
Non-Conformance Control
- Documented process for identifying, recording, and dispositioning non-conformances
- Corrective action records retained
Declaration of Conformity and Marking
- Signed Declaration of Conformity issued by the manufacturer
- CE or UKCA marking applied to the equipment
- Instructions for use issued with the equipment
THE GC LOGICALS APPROACH
GC Logicals provides end-to-end PED and PESR compliance support for fabricators and design houses — whether you are building a compliance system from scratch, preparing for a specific project, or addressing findings from an audit or enforcement action.
Services include:
- Categorisation Assessment — determining whether your equipment is SEP, Category I, II, III, or IV
- Module Selection — identifying the correct and most practical conformity assessment route for your product and business
- Technical File Compilation — building the complete documented evidence package required to support your Declaration of Conformity
- Welding Compliance — WPS, WPQR, weld mapping, and welder qualification to satisfy the ESR welding requirements
- QMS Development — building the quality management system infrastructure required to support Module D, H, or H1 assessment
- Approved Body Liaison — managing the interface with your Notified or Approved Body on your behalf
- Gap Analysis — assessing your current position against the full ESR and conformity assessment requirements and identifying what needs to be done
START THE CONVERSATION….
PED and PESR compliance does not have to be complicated — but it does have to be right. If you are unsure whether your equipment is in scope, which category it falls into, or what you need to do to demonstrate compliance, the right place to start is a straightforward conversation.
The first consultation is free. You will get a straight answer.
CALL US ON 07840 037953