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Additive manufacturing and the PED

"Our casting is no longer available — may I print it?" That one question contains four legal questions that get mixed up. Below they are pulled apart, each answer with its reference. Your category is not the problem; your material evidence is.

PED-CheckGuide › Additive manufacturing

At a glance

The AM route across four pages — what is where

This guide is split over four pages, in the order in which the questions arise in a project. Starting from scratch, work through them top to bottom. Looking for one answer, go straight in.

  1. This page — regime and category. The route wizard · what “may I print this” actually consists of · question 1: new product or replacement · question 2: does AM change the category · question 3: the material, in brief
  2. Material and PMA — question 3 in full. Which of the three material routes applies, what belongs in a particular material appraisal, test directions and anisotropy, the material manufacturer's quality system, and whether your DNV or API qualification counts.
  3. Processes, personnel and NDT — question 4. Which process family you use and what that changes legally, point 3.1.2 on a fully printed part, qualification without a harmonised standard under Guideline F-06, and non-destructive testing.
  4. Technical file and sector frameworks. What the notified body wants to see on the table, and how DNV-ST-B203, API 20S and the ISO/ASTM 52926 series relate to the PED.

Two in-depth pages sit alongside that route, for anyone looking beyond one project: European approval for materials and your PMA library — material evidence you reuse · Standards in development — EN 13445-14 and what harmonisation takes.

Then: the feasibility check — your part put through the same route, with the outcome on paper.

What do I have to do to have this part made additively?

Six choices. The outcome is your complete route: which regime applies, how you demonstrate the material, what qualification and NDT you need, and which documents belong in the file. Free, and you leave nothing behind.

Relevant only for replacement: the in-service phase is not harmonised across the EU.
Additive manufacturing does not change the category. If you do not know it, work it out first with the free PED check — it takes a minute.

What "may I print this" actually consists of

Customers ask one question. It contains four, and they are almost always conflated:

  1. Is this a new product or a repair? This decides whether the PED applies at all.
  2. Does additive manufacturing change the category? No — and that helps less than you hope.
  3. How do you demonstrate the material? This is where the work is, and where projects stall.
  4. How do you qualify process, personnel and NDT? This is where the money is that nobody budgets.

Four words that get conflated

A directive, national regulations, guidelines and standards all appear on this page. They do not carry equal weight, and that difference decides how firmly you can make a statement. So, the hierarchy first:

Directive 2014/68/EU (PED)European legislation. Binding. States what must be achieved.BINDINGWBDA and WRDA 2016Dutch regulations for the in-service phase. Binding.BINDINGPED GuidelinesInterpretation by the European Working Group “Pressure”. Not binding, but authoritative.GUIDANCEStandards (EN, ISO/ASTM, DNV, API)Voluntary. Only a harmonised standard confers a presumption of conformity.VOLUNTARYheavierlighter

The directive is the European law: Directive 2014/68/EU, the PED. Regulations here means the Dutch track for the in-service phase, the Pressure Equipment Decree and Regulation 2016. A guideline is something else: the interpretation the European Working Group “Pressure” gives at difficult points in the directive. That interpretation is not legally binding — the set says so itself — but notified bodies and market surveillance authorities follow it in practice, so you rarely win an argument by contradicting it. A standard, finally, is always voluntary; only a harmonised standard delivers the presumption of conformity.

First, on the status of this page: the PED does not mention additive manufacturing anywhere, and the Working Group “Pressure” has issued no guideline on it — the consolidated set (version 6.0) contains no reference to additive manufacturing at all. Wherever legal text or a guideline governs below, the reference is stated. Wherever it is my reading, that is said in so many words.

Question 1: new product or replacement?

This is the most important split and the most frequently overlooked one. It decides whether you run a full conformity assessment or a considerably lighter route.

1. Placed on the market on its own?as pressure equipment, an assembly or an accessoryFull PED routecategory, module, CE markingyesno2. Already in service in the Netherlands?installed and put into operationOutside NL: national lawof the member state of usenoyes3. Substantial modification?other pressure, function or pressure-bearing structurePlaced on the market anewfull PED route, as a new productyesnoRepair or replacement (WBDA Art. 26)Annex I applies mutatis mutandis, inform the bodyno new CE marking

The Working Group Pressure answered this explicitly in PED Guideline A-03. Three situations, three outcomes:

SituationRegimeConsequence
The part is placed on the market as pressure equipment, an assembly or an accessory — or the entire item is replaced by a new oneFull conformity assessment under the PEDCategory under Annex II, module under Art. 14, CE marking, notified body from category II
The part repairs or replaces a component of equipment already in serviceNot the PED, but national law — in the Netherlands the WBDA 2016Article 26 WBDA: Annex I applies mutatis mutandis, the designated body is informed without delay, no new CE marking
The part brings a substantial modification that changes the original characteristics, purpose and/or typePlacing on the market anew: the PED, as a new productFull route. Where the line lies is assessed case by case — the guideline says so in as many words

Most "our casting is no longer available" questions fall in the second row. Your supplier will not tell you that, because he would rather sell you a new item. Your inspection body will not volunteer it either, because it only receives the question once the decision has been made.

Watch the third row. A one-for-one replacement of an impeller or a valve body is usually a repair. The same replacement in which you adjust the wall thickness, the connection size or the design pressure may tip over into "placing on the market anew". That is exactly the point at which the assessment can no longer be made on instinct. Note also the jurisdiction: the repair route is Dutch law. The PED harmonises placing on the market; what happens to equipment in service is left to each member state. If your equipment operates elsewhere, the split still follows Guideline A-03, but the obligations replacing the PED are those of the member state of use. The Dutch in-service rules have their own page.
References: PED Guideline A-03 (to Art. 1 and Annex I point 3.4) in the consolidated set version 6.0 of the Working Group Pressure; Dutch Pressure Equipment Decree 2016 (WBDA) Art. 26 (repair and modification); Art. 2(17) and Art. 2(18) of the directive (placing on the market, putting into service).

Question 2: does additive manufacturing change the category?

No. Annex II classifies on equipment type, phase, fluid group and the figures PS and V or DN. There is no process parameter in it. An additively manufactured vessel of 11 bar and 500 litres holding compressed air lands in exactly the same category as the same vessel made from plate. You can verify that yourself with the free check.

That is the reassuring part. The difficult part is the sentence behind it: what changes is the burden of proof within that category. For a cast or rolled part you take a harmonised material standard and you are done with Annex I point 4.2. For an additively manufactured part that standard does not exist, and then the work described in the rest of this page begins.

Practical consequence: work out where you sit before you commit to an AM route. If you land in category I there is no notified body and no approval requirement for joining procedures — the route is far shorter than the literature suggests. If you land in III or IV, the specific assessment of the material by the notified body is unavoidable and it sets the lead time of your entire project.

Question 3: the material — in brief

This is the centre of gravity of the whole project and therefore has its own page. The short version: there is no harmonised AM material standard, so the presumption of conformity falls away and the route runs through a particular material appraisal (Annex I point 4.2(b), third indent) or, rarely, a European approval for materials (Article 15). From category III the notified body appraises that document separately (point 4.2(c)).

1. Which route?a harmonised standarddoes not exist for AM→ so PMA or EAM2. What do you fix?material andprocess windowas one whole3. How do you test?in more than onedirection; demonstratethe anisotropy4. Who assesses?you draw it up;from category IIIthe NoBo assessesTraceability runs underneath all four: to the batch and to the buildAnnex I point 3.1.5; for the main pressure-bearing parts of categories II–IV a 3.1 on the part (point 4.3)

The four steps are worked out on Material and the particular material appraisal: which route, what you fix, how you test and who appraises.

AM–PED feasibility check — € 450 excl. VAT

The page above answers the general question. The question that costs money is the specific one: will thís part pass, along which route, and what will the testing cost? That is what this is for.

What you get: a memo of four to six pages on one specific part, within five working days of receiving the data. Fixed price, no hourly billing afterwards.

  1. Regime determination — new on the market or replacement under Art. 26 WBDA, with the reasoning behind it.
  2. Category and module — calculated with the same engine as the free check, with the table and the limit values around it.
  3. Material route — which PMA evidence is needed, which tests, in which directions, and which harmonised standard for a similar grade you have to weigh in.
  4. Qualification plan — build procedure and operator, who approves what, and from which category that has to be a notified body or a recognised third-party organisation.
  5. NDT plan — method per surface, acceptance criterion with justification, and the machining question priced explicitly.
  6. File list and bottlenecks — what the technical file must contain, plus a realistic estimate of lead time and where it goes wrong.

What I need: a drawing or 3D model, the intended material and process, PS and V or DN, the medium and operating temperature, and whether the equipment is new or already in service. The request form asks for that in four steps; you receive a file number and a link to come back to it.

Request the feasibility check

The request itself is free and without obligation: within two working days you hear whether the part lends itself to this and what the check would cost in your case. Already have a file? Open it on the file page.

This is advice on the route and the evidence, not a conformity assessment. The assessment itself remains with the manufacturer and, where the directive requires it, with a notified body. The in-service part of the memo covers Dutch law; for equipment operated elsewhere it identifies what to check in the member state of use.

Frequently asked questions

Does additive manufacturing change my PED category?

No. Annex II classifies on equipment type, phase, fluid group and the figures PS and V or DN; there is no process parameter in it. What changes is the burden of proof within the category: without a harmonised material standard the material route runs through a particular material appraisal or a European approval for materials.

May I replace a casting with a printed part?

If the equipment is already in service, PED Guideline A-03 puts this outside the PED and inside national law. In the Netherlands Article 26 of the Pressure Equipment Decree 2016 then applies: Annex I applies mutatis mutandis, the designated body is informed without delay, and no new CE marking goes on. If the replacement changes the original characteristics, purpose or type, it counts as placing on the market anew and you run the full PED route. Outside the Netherlands the split follows the same guideline, but the in-service obligations are those of the member state of use.

Is there a harmonised standard for additive manufacturing under the PED?

No. The list of harmonised standards under Directive 2014/68/EU as compiled on 13-01-2026, following Commission Implementing Decision (EU) 2026/79, contains no AM standard: not the ISO/ASTM 52900 series, not AWS D20.1, no EN part on additive manufacturing. There is therefore no presumption of conformity along that route.

First find out which category your part falls in

The free check gives the table, the category and the permitted modules — identical for a printed and a cast part. After that you know which evidence you have to build.

Run the free check or see the full report

Further reading