At a glance
- No AM standard at all is harmonised under the PED — checked against the list of 13-01-2026. Route 1, the presumption of conformity, is therefore not available.
- What remains is a European approval for materials (Article 15) or, in practice, a particular material appraisal under Annex I point 4.2(b), third indent.
- From category III onwards that appraisal is specifically appraised by the notified body (point 4.2(c)). That is a milestone of its own with a lead time of its own, and the longest step in the route.
- The manufacturer draws up the appraisal, the body appraises it. The other way round cannot work: it would be appraising its own work.
Why material works differently here
A rolled plate or a casting is made, inspected and only then sold. The material evidence belongs to the product and travels with it. In additive manufacturing you buy wire or powder, and that is the feedstock. The material your design rests on comes into being in your own machine: layer by layer, with a thermal history that differs from place to place within the part.
Everything on this page follows from that. The properties that carry your design are properties of the built volume, not of the feedstock — and you have to demonstrate them, in the directions in which the load acts.
The directive does not say this in AM terms, because it knows no manufacturing process. It says: the material must be suitable for the intended use and that must be demonstrated (Annex I point 4.1), and for the main pressure-bearing parts of categories II to IV that includes an inspection document 3.1 in accordance with EN 10204 (point 4.3). The filler material itself need not meet point 4.2(b); a 2.2 suffices there (PED Guidelines G-10 and G-12).
Three routes, and which one applies to you
The directive gives three ways of demonstrating that a material is sound. They are mutually exclusive: you take one.
Route 1 — a harmonised material standard
If the material complies with a standard whose reference is published in the Official Journal, the presumption of conformity with the corresponding essential safety requirements applies (Article 12). Nothing further needs to be substantiated.
In AM this route is not available. The list of harmonised standards under the PED, generated on 13-01-2026 following Implementing Decision (EU) 2026/79, holds 689 references and not one of them is an additive manufacturing standard. The ISO/ASTM 52900 series, the 52926 parts and DNV-ST-B203 are all absent. They are usable as substantiation, but they give no presumption of conformity.
Route 2 — a European approval for materials (Article 15)
This route is worked out in full on European approval for materials and your PMA library: the five steps of Article 15, a worked example, and whether a printer can build appraisals in advance.
If a European approval exists for your material, issued by a notified body specifically designated for that task, you use it and need no substantiation of your own. This is the shortest route, but for AM materials the offering is currently thin: check with your intended body before assuming it.
Route 3 — the particular material appraisal
If the first two are empty, the particular material appraisal remains: Annex I point 4.2(b), third indent, commonly abbreviated to PMA. It is a document you draw up as manufacturer and that becomes part of your technical file. PED Guideline I-13 describes what belongs in it; document PE-03-28 of the notified bodies works that out further.
Note the division of roles. The manufacturer draws it up. Ask the notified body to write it and it would later have to appraise its own work — which it cannot, and you are turned down. This is the misunderstanding that most often costs time.
What belongs in a particular material appraisal
Five questions, in this order. Answer all five with reference to test reports and you have a file that survives an appraisal.
1. What the material is
Material number or grade, chemical composition with tolerances, and the delivery condition of the filler material. Name the standard the wire or powder complies with as well — that is not the same as a standard for the part, but it belongs in the file.
2. How it is made
This is where AM differs from a conventional material. Record material and process window as one whole: build direction, layer build-up and thickness, heat input or energy density, interlayer temperature, build chamber atmosphere and shielding gas, and the post-build heat treatment. Outside that window your substantiation no longer holds.
Practical consequence: the process window is a material datum, not a manufacturing detail. Treat it as a work instruction and later rotate the build direction “just this once”, and you have built a part for which no substantiation exists.
3. What the material can do
The mechanical properties your design uses, at the design temperature: proof strength, tensile strength, elongation after fracture, impact energy. Creep properties where the temperature calls for them. Corrosion resistance against the fluid. And all of it per build direction — see the next block.
4. What it is compared against
PED Guideline I-13 names this explicitly: the properties of a comparable, qualified material kind are the yardstick. Name that standard with its number and put side by side what the standard requires and what you measured. An appraiser who cannot place your figures cannot accept them.
5. How it is proven
Test reports with the number of specimens, their location and orientation in the built volume, the methods used and the acceptance criteria with their origin. Traceability to the charge of filler material and to the build run (Annex I point 3.1.5).
Directions: why one tensile specimen is not enough
A rolled plate is not identical in every direction either, but the deviation is known and standardised. In an additively built volume the weak direction is perpendicular to the layers, and how weak depends on your process window. There is no table for that: you measure it.
Two identical parts, built differently, give different numbers — and that difference is exactly what an appraiser wants to see substantiated:
An appraisal with tensile specimens in one direction is therefore incomplete. Test in at least two directions and design with the lowest value — unless you demonstrate in the design that the load never acts in the unfavourable direction, and fix that in the build orientation.
This is the item on which files stall in practice. Not because the material is unsound, but because the appraiser cannot establish where the measured value came from.
When it has to be finished
The order matters more than the duration. Everything below comes before the first production layer.
In categories III and IV the specific appraisal by the notified body is added (point 4.2(c)). Plan it as a milestone of its own with its own lead time; in almost every project it is the longest step. Start that conversation with the body before you build — not once the part is lying there.
In categories I and II the appraisal stays in your own technical file. That does not make it lighter: it means nobody sees it in advance, and that an inspectorate or a customer can ask for it afterwards.
“I already have a DNV or API qualification — is that not enough?”
Almost. This is the question most often asked by companies already working under a sector framework, and the answer is no, but it saves most of the work. The overlap is large; the gaps are specific and predictable.
Why it does not cover it by itself
A qualification campaign and a material appraisal serve two different purposes in the directive. Qualification of procedures and personnel sits under Annex I point 3.1.2: can this process, with these people, make a sound permanent joint. The material appraisal sits under point 4.2: is this material, in this form, suitable for this use. Passing one does not discharge the other — they are in different chapters of Annex I for a reason.
In practice the gaps sit in four places almost every time:
- Temperature. A qualification tests at the temperature the qualification standard prescribes. The PMA has to give the properties at your design temperature. Impact energy at −20 °C says nothing about equipment running at 250 °C, and the other way round.
- Direction. Qualification specimens are oriented on the joint, or on the coupon as the standard prescribes. For a fully deposited volume the unfavourable build direction has to be added, if it was not already covered.
- Fluid. No welding or AM qualification standard tests corrosion resistance against your fluid. Annex I point 4.1 asks for suitability for the intended use, and that includes what is inside.
- Comparison and coverage. A qualification report contains no comparison with a harmonised standard for a comparable kind (PED Guideline I-13, note 2), and the range of validity of the qualification is not the same as the thickness and geometry range your part needs.
What you can reuse
Nearly all of it. Tensile and impact values, hardness, macro and micro examination, the recorded process window and the traceability of the specimens are all usable as evidence within the particular material appraisal. A DNV or API certificate then becomes an annex under your own document, not a replacement for it: the PMA remains a manufacturer’s document that becomes part of the technical file (Guideline I-13).
The saving is in the sequence
This is where money is either lost or kept. Draw up the PMA test plan before you set up the qualification campaign and you lay out the coupons so that one campaign serves both purposes: extra specimens in the second direction, impact also at the design temperature, a corrosion coupon from the same build run. That is a marginal addition to a campaign you were running anyway.
Start the PMA once the qualification is finished and half the required values turn out not to have been measured, so you test a second time — new specimens, a new build run, a new lead time. In categories III and IV the notified body’s appraisal time comes on top of that.
Rule of thumb: write down first which properties your design uses and at which temperature, and derive the specimen list from that. The qualification standard then sets the minimum; your design sets the rest.
The material manufacturer's quality system
Annex I point 4.3 requires the equipment manufacturer to take appropriate measures to ensure that the material used conforms with the required specification, and to obtain documentation from the material manufacturer for all materials. For the main pressure-bearing parts of equipment in categories II, III and IV a certificate of specific product control is required. Where the material manufacturer has an appropriate quality system — in practice of at least EN ISO 9001 type, certified by a competent body established within the Union and having undergone a specific assessment for materials — an inspection document from that manufacturer is appropriate.
In additive manufacturing traceability has to run through to the batch and the build, not merely to the delivery note. Powder processes add a question wire does not raise: how many times has this powder been re-used, and how do you show its properties have not drifted?
Six mistakes that cost money
- Submitting the wire supplier’s certificate as material evidence. That document is about the feedstock. The directive asks for the properties of the built volume.
- Having the notified body draw up the appraisal. It appraises; you draw up. The other way round fails on independence.
- Testing in one direction. Without a second direction there is no statement about anisotropy, and therefore no usable design value.
- Treating the process window as a work instruction. Change the build direction or the heat input and the part falls outside the substantiation.
- Planning the appraisal after building. In categories III and IV that is weeks of delay; at worst you build again.
- Copying acceptance criteria from a welding standard. The levels of ISO 5817 are written for joints between parts, not for a fully deposited volume. Substantiate per defect type which criterion you apply and why — PED Guideline F-06 names the elements needed for that.
What the sector frameworks add here
DNV-ST-B203 (edition November 2025) and API 20S give a structured way of building exactly this substantiation: qualification of material, process and personnel, with a classification by criticality — AMC 0 to 3 in DNV, AMSL 1 to 3 in API. If you already work under such a framework, most of the evidence exists and translating it into a PMA is largely a matter of ordering it.
But: neither is harmonised under the PED. They deliver substantiation, not a presumption of conformity. In your file you therefore do not cite the framework as the basis, but Annex I — with the framework as the evidence underneath it.
Frequently asked questions
Is a PMA mandatory for 3D-printed pressure equipment?
Not as such. What is mandatory is that the material is suitable for the intended use and that you demonstrate it (Annex I points 4.1 and 4.2). There are three ways of doing that. Because no AM standard is harmonised and European approvals for AM materials are scarce, in practice you almost always end up with the third: the particular material appraisal.
Can I use the material certificate from my wire supplier?
For the filler material itself an inspection document 2.2 suffices (PED Guideline G-10), and the filler material need not meet Annex I point 4.2(b) (Guideline G-12). But that document says nothing about the built volume. For the main pressure-bearing parts of categories II to IV, point 4.3 asks for an inspection document 3.1 on the part.
Who appraises the particular material appraisal?
In categories I and II nobody does so in advance: it stays in your technical file. From category III it is specifically appraised by the notified body (Annex I point 4.2(c)). Allow for a separate lead time and start that conversation before you build.
In how many directions must I test?
The directive names no number. What it asks is that the properties are demonstrated for the intended use. Because an additively built volume is direction-dependent, in practice that means at least two directions: parallel to the layers and perpendicular to them. Design with the lowest value and the substantiation is closed without assumptions about the load direction.
Do DNV-ST-B203 or API 20S give me a presumption of conformity?
No. Neither appears in the list of harmonised standards under the PED. They are excellent as substantiation: they structure the qualification of material, process and personnel, and an appraiser recognises that structure. In your file the basis is Annex I; the sector framework is the evidence underneath it.
I already have a welding or AM qualification under DNV-ST-B203 or API 20S. Does that serve as a PMA?
No, but it saves most of the work. The qualification sits under Annex I point 3.1.2 (procedures and personnel), the material appraisal under point 4.2 (the material itself). The test results from the qualification are perfectly good evidence within the PMA. What usually has to be added: the same properties at your design temperature, the unfavourable build direction, corrosion or fluid compatibility, creep where the temperature calls for it, the comparison with a harmonised standard for a comparable kind, and coverage of your part’s wall thickness. Draw up the PMA test plan before you set up the qualification campaign and you test once instead of twice.
My part falls under Article 4(3). Do I still need a PMA?
No. Under Article 4(3) Annex I does not apply (PED Guideline I-12), so point 4.2 does not either. You design and build in accordance with sound engineering practice. That does not mean you record nothing: your customer or an inspectorate can ask why the equipment falls under Article 4(3), and that answer belongs on paper.
May I use powder or wire supplied to an ASME specification?
Yes, but the ASME specification does not do the work for you. The PED does not mutually recognise ASME material; you substantiate suitability in a particular material appraisal. Guideline I-13 requires you to take into account the properties from a harmonised European standard for a comparable grade — impact energy, elongation after fracture and corrosion resistance.
Which route applies to your part?
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