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European approval for materials and your own material library

A particular material appraisal is yours and covers your part. A European approval for materials belongs to everyone and covers the material. That difference decides whether you start from scratch on every project or build evidence that stays. This page puts the two routes side by side, with the Article 15 procedure and a worked example.

PED-CheckGuide › European approval for materials

At a glance

What a European approval for materials is

Annex I point 4.2(b) gives three ways to demonstrate that a material is suitable: a harmonised material standard, a European approval for materials, or a particular material appraisal. The first does not exist for additively manufactured material. The third you know — it is worked out on Material and PMA. The second is almost always skipped, which is a pity, because it solves a problem a PMA cannot solve: transferability.

A European approval for materials is a document about a type of material, not about your part. It is issued by a notified body that its Member State has specifically designated for this task — not every notified body may do this. The request comes from one or more manufacturers of the material or of the equipment. The body defines and carries out, or has carried out, the examinations and tests needed to certify that the type of material conforms with the requirements of the directive.

Once the Commission publishes the reference in the Official Journal, anyone using that material under those conditions may rely on it. That is the difference with a PMA in one sentence.

References: Article 15 (European approval for materials), Article 20 (notification and designation of bodies), Annex I point 4.2(b), second indent (the material route), and Article 11(2) of Directive 97/23/EC as its predecessor. Checked 01-09-2026.

The Article 15 procedure, step by step

1. Requestby a manufacturer ofmaterial or equipment2. Examinationdesignated notifiedbody tests3. NotificationMember States and theCommission: 3 months4. Issueapproval and copiesto all parties5. Publicationreference in theOfficial JournalArticle 15(1) to (4)What you then havepresumption of conformity for the material(Annex I point 4.2(b), second indent)What can take it awaythe body withdraws it if the approval wasunjustified or a standard now covers the material (15(5))

Step 1 — request. You apply, either as the manufacturer of the material or as the manufacturer of the equipment. For WAAM that distinction is less sharp than it looks: the material comes into being in your machine, so you are in effect also the material manufacturer. That is a stronger argument for your request than most applicants use.

Step 2 — examination and testing. The designated body determines which examinations and tests are needed to certify conformity of the type of material. It may carry them out itself or have them carried out. For materials recognised as safe to use before 29 May 1997 it takes existing data into account — a provision that does not help you with an AM material, which did not exist then.

Step 3 — notification and three months. Before issuing, the body notifies the Member States and the Commission, sending the appropriate information. They have three months to comment, stating reasons. This is the step that wrecks planning: it is fixed, outside your control, and comes on top of the testing time.

Step 4 — issue. A copy of the approval goes to the Member States, the other notified bodies and the Commission.

Step 5 — publication. Where the approval satisfies the requirements it covers, the Commission publishes the reference and keeps an updated list. Only then does the presumption of conformity work.

And it can be taken away. The body that issued the approval withdraws it if it finds it should not have been issued, or if the type of material becomes covered by a harmonised standard (Article 15(5)). For AM that is not a theoretical risk: if a harmonised AM standard ever arrives, your approval falls away as soon as that standard covers the material. See Standards in development.
References: Article 15(1) to (5); Article 20 (designation of the body); Annex I point 4.2(b), second indent.

A worked example

Fictional, but with realistic proportions. A supplier builds pressure-bearing transition pieces in a low-alloy steel with DED-arc, from one wire grade, with one fixed process window and one fixed heat treatment. He supplies six different customers, each carrying its own manufacturer role under the PED.

 Six PMAs (one per customer)One European approval for materials
Who prepares iteach customer, using your datayou, as the applicant
Testingin practice six comparable test series, because each notified body wants its own viewone series, defined by the designated body
Lead time per projectweeks to months, every timenone, once published
Lead time up frontnonetesting plus three months for comments plus issue and publication — count on more than a year
Who may use itonly the customer it was prepared foranyone, including your competitor
When it pays offwith little repetition, or parts that differ every timeif you sell the material itself, or the repetition is large and long-term

That last row is the heart of it. An EAM is not an efficiency measure inside one project but a market strategy: you make your material usable for the whole market, including parties who pay you nothing. Attractive if you sell the wire, the powder or the machine; unattractive if your edge sits precisely in that material evidence.

How rare is this route? As far as is publicly known the EAM has been used only a handful of times since the directive came in; trade sources name low-carbon nickel in a few product forms. I have not been able to make a complete count of the published references — the Commission publishes that list in the Official Journal. Assume that for an AM material you would be the first, with the lead time that implies.

PMA or EAM: the two side by side

Particular material appraisal (PMA)European approval for materials (EAM)Whose it isyours, for this partanyone's who uses itWho appraisesyour notified body, from cat. IIIa body designated for that taskWhere it livesin your technical filereference in the Official JournalLead timeweeks to monthsa year or more, plus 3 months for commentsTransferablenoyes — that is the whole pointReferenceAnnex I 4.2(b), 3rd indentArticle 15; 4.2(b), 2nd indent

The question to ask yourself is not “which is better” but “who has to be able to rely on this”. Only you, for this part? Then a particular material appraisal. Your customers, your licensees, the market? Then the EAM is the only route that delivers that in law.

A third possibility that is often forgotten: you prepare a PMA, have it appraised by the notified body within one project (Annex I point 4.2(c)), and then use that same file as supporting evidence on later projects. That is not a formal transfer — every new manufacturer remains responsible for its own demonstration — but in practice it removes most of the testing work.

Can an AM producer build its own PMAs for common materials?

Yes. This is the question most often answered with “surely that is not allowed”, and that answer is wrong. Annex I point 4.2(b), third indent, says nothing about who prepares the particular material appraisal, or when. The manufacturer of the equipment is responsible for the demonstration; nothing prevents him from building that demonstration in advance, outside a running project.

S355-class wireDuplexNickel alloyDED-arc, as-builtPMA readyPMA readystill to doDED-arc, heat treatedPMA readystill to dostill to doDED-arc, machined facePMA readyPMA readystill to doEvery green cell is a quotation you can issue within a dayThe cell holds as long as material, process window and heat treatment stay insidethe qualified range. Outside it: extend the appraisal or test again.

Think in cells, not in projects. A cell is a combination of a material (wire or powder specification) and a process window (parameter range, build directions, interpass temperature, heat treatment, surface condition). For each cell you build the evidence once: test pieces, testing in at least two directions, comparison against the properties from a harmonised standard for a comparable grade. After that the cell is reusable.

What that does get you

What it does not get you

Where the cell cracks

A library is only worth something if the range of validity is fixed hard. These changes fall outside an existing cell and require extension or new testing:

ChangeEffect on the cell
A different wire or powder specification, even at the same strength classnew cell — the chemistry co-determines the properties
Parameters outside the qualified range (current, speed, heat input, interpass temperature)extension with additional test pieces
A changed or omitted heat treatmentnew cell — this is the single largest influence on the properties
A build direction outside the tested rangeextension; the weak direction must stay covered
As-built where you qualified machined (or the reverse)new cell for the NDT and the surface condition
A different machine or installation with different thermal behavioursubstantiate that the process window transfers, otherwise extend
My reading, not legal text. The directive does not use the notion of a “PMA library” and says nothing about appraisals built in advance. What is above follows from what Annex I point 4.2 does and does not require, and from how notified bodies handle it in practice. Put the arrangement to the body you work with beforehand; that costs one conversation and saves a repeat test campaign.
References: Annex I point 4.2(b), third indent (particular material appraisal) and point 4.2(c) (specific appraisal from category III), point 4.3 (documentation and traceability), point 3.1.5 (traceability); PED Guideline I-13 (formal requirements of a particular material appraisal, referring to PE-03-28).

Which route do you choose

Your situationRoute
One part, one customer, no repetitionParticular material appraisal inside the project
Recurring work in a few fixed materials and process windowsA library of particular material appraisals, built in advance
You sell the material or the machine and want customers to rely on itEuropean approval for materials — the only transferable route
You want to keep the competitive edge your material evidence gives youNo EAM: publication makes it usable by everyone
Your material is covered by an existing harmonised material standardThat standard; an EAM cannot then be issued and a PMA is unnecessary

Frequently asked questions

What is the difference between a PMA and a European approval for materials?

A particular material appraisal (PMA) belongs to your equipment, sits in your technical file and is specifically appraised by your notified body from category III onwards (Annex I point 4.2(c)). A European approval for materials belongs to the material, is issued by a notified body designated for that task, and its reference is published by the Commission in the Official Journal (Article 15). After that anyone may rely on it. In short: the PMA is yours, the EAM belongs to the market.

How long does a European approval for materials take?

The directive sets no overall lead time, but it does set one hard period: after the notified body notifies its intention to the Member States and the Commission, there are three months for comments (Article 15(2)). Defining and running the tests comes before that, and issue and publication after. Plan for well over a year and do not treat the EAM as a route for a running project.

May I as a printer prepare and keep particular material appraisals myself?

Yes. Annex I point 4.2(b), third indent, sets no requirement as to who prepares the appraisal or when. You can build evidence in advance for each combination of material and process window and reuse it as long as you stay inside the qualified range. What you do not get is approval up front: the notified body appraises the appraisal within the conformity assessment of specific equipment, and a customer who is himself the manufacturer remains responsible.

When does an existing material appraisal lose its validity?

As soon as you move outside the range you demonstrated: a different wire or powder specification, parameters outside the qualified window, a changed or omitted heat treatment, a build direction that was not tested, or a move from machined to as-built. A European approval for materials has its own ground for withdrawal on top of that: the body withdraws it if it should not have been issued or if a harmonised standard comes to cover the type of material (Article 15(5)).

Can I apply for an EAM for a material already covered by a harmonised standard?

No. Annex I point 4.2(b) has an order to it: if a harmonised material standard covers your material, the demonstration runs along that route. A European approval for materials is meant for materials developed outside standardisation, and Article 15(5) makes the approval fall away as soon as a standard comes to cover the type of material.

Which material route applies to your part?

The route wizard settles in six choices which regime, which material route and which qualifications apply to your case. Free, and you leave nothing behind.

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Further reading