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Repair, modification or a new product: where is the line?

A repair does not fall under the Pressure Equipment Directive. A substantial modification produces a new product, with a new conformity assessment, a new declaration and a new CE marking — in the name of whoever carried out the modification. Between those two lies the line on which maintenance contractors and users founder in practice. This page sets out the three-way split, with what Dutch law adds to it in the service phase.

PED-CheckGuide › Repair and modification

At a glance

What you will find on this page

  1. The three-way split — replacement, repair and substantial modification
  2. When it becomes a new product — the three criteria, and what is then required
  3. The Netherlands: Article 26 — step by step, and who assesses what
  4. Who carries which duty — and why the decree does not mention you at all
  5. Safety accessories and valves — the heaviest case, and where the source is silent
  6. What it does to the inspection interval — and when a duty of inspection arises
  7. Five misconceptions — with the provision that refutes each

The three-way split: three kinds of work, three regimes

1. Are you replacing the whole item?not a component, but the item of pressure equipmentNew pressure equipmentthe PED covers it (guideline A-03, case 1)yesno2. Do the performance, purpose or type change?and was that not foreseen in the initial risk assessmentRepairnot the PED but national law · NL: WBDA Art. 26noyes3. Does the nature of the hazard change, or the risk rise?the second condition of the Blue GuideStill a repairthe repair regime continues to applynoyes4. Is it made available or put into service again?the third condition — all three must hold togetherStill a repairno new product without this stepnoyesSubstantial modification: a new productnew assessment, new declaration, new CE marking — and you are the manufacturer

The directive does not govern the service phase. It does mention maintenance — Article 3(1) requires equipment to be properly installed and maintained, and Annex I builds design requirements around it in 2.9, 2.11.1, 3.4 and 6 — but those are requirements on the manufacturer. What it governs is the making available on the market and the putting into service (Article 3(1), with the definitions of Article 2(16) and (17)); recital 4 makes clear that it is about equipment which is new on the Union market. What happens to the item afterwards is in principle a matter of national law. The Working Group Pressure worked that line out in guideline A-03, which distinguishes three cases:

What you doWhat it isWhat applies
Replacing the whole item of pressure equipment with a new oneplacing a new item on the marketThe PED in full: category, module, technical file, declaration, CE marking. This case is not about a component but about the item itself
Repairing — restoring the original conditionno new productThe PED does not apply. National law does, “if any” as the guideline puts it. In the Netherlands there is such law: Article 26 of the WBDA 2016
Modifying substantially — changing the original characteristics, purpose or typea new productA full new conformity assessment, with a new manufacturer. The guideline says expressly: to be judged case by case
What A-03 does not say. The first case is about replacing a complete item of pressure equipment, not about replacing a component with an identical one. On that far more ordinary act the guidelines give no rule: there is no guideline on replacing a component of equipment in service. What does exist touches the manufacturing phase — guideline H-19 on marking and the spare parts list for equipment sold separately as a spare part, and A-22 on component parts incorporated into an item. The Blue Guide catches it with the rule that maintenance operations are in principle outside the scope — but that is a Commission notice, not a binding interpretation. And note: the replacement part must itself meet whatever applies to it; where it is pressure equipment placed on the market in its own right, it needs its own declaration.
References: Article 3(1) (making available and putting into service, including the requirement of proper installation and maintenance); Article 2(16) and (17); recital 4; Annex I, 2.9, 2.11.1, 3.4 and 6; guideline A-03 (bundle v6.0, under Article 1 and Annex I, 3.4); Blue Guide 2022 § 2.1, under the heading on repairs and modifications. The guidelines are adopted in English only and are not a binding interpretation of the directive. Checked 17-09-2026.

When does it become a new product?

The directive gives no test, the Blue Guide does. It sets out three conditions that must hold together before a modified product is regarded as a new product:

  1. The original performance, purpose or type has changed, and that change was not foreseen in the initial risk assessment.
  2. The nature of the hazard has changed or the level of risk has increased.
  3. The product is then made available on the market or put into service.

Note what is not in there: the size of the job, the cost, the number of parts replaced, whether welding was involved. A large but identical repair stays a repair; a small intervention that raises the design pressure or changes the fluid can produce a new product.

Where it is a new product, the whole chain shifts. Whoever carried out the modification becomes the manufacturer within the meaning of Article 2(18) — even where he sells nothing, because that definition expressly covers using it for his own purposes too. He carries out the conformity assessment of Article 14, draws up an EU declaration of conformity and affixes the CE marking with his own name and address (Articles 6 and 19). The technical documentation need not be rebuilt from scratch: it is updated in as much as the modification has an impact.

A user who modifies becomes the manufacturer too. That is no theoretical possibility. Article 2(18) does not look at your line of business but at what you do. Anyone who adapts a vessel in-house and then puts it into service again has taken over the role; in the Netherlands that runs via Article 17a of the WBDA, with an NL conformity assessment body and an NL declaration of conformity instead of a CE marking.
References: Blue Guide 2022 § 2.1 (the three cumulative conditions) and § 4.5.1.6 (CE marking after a substantial modification); directive Article 2(18), Article 6, Article 14, Article 17 and Article 19; WBDA 2016 Article 17a. See also assemblies under the PED for who is the manufacturer of a connected whole.

The Netherlands: Article 26 of the WBDA 2016

This is the provision the guideline means by “national law, if any”. It does not apply to all pressure equipment: Article 26(1) refers to the equipment of Article 21(1), which is the equipment designated as subject to inspection by ministerial regulation. If your equipment is not covered, there is no Article 26 regime — and all that remains is the general duty of care and the Working Conditions Decree. Work it out with the Dutch inspection check.

The steps of Article 26

  1. Annex I applies again, mutatis mutandis — except for affixing the CE marking (paragraph 1). So you build the same substantiation as for new construction: material, welding procedures, personnel, examination. Only the closing act of the CE phase falls away.
  2. The body is notified without delay (paragraph 2). That is done by the user, not by you — but if it does not happen, your work stops or is disputed afterwards.
  3. The intended modification or repair is assessed beforehand: the body carries out the necessary examinations of the design and construction, and performs tests during the work (paragraph 3). Beforehand, not afterwards.
  4. A modification can escalate to the regime of the periodic re-inspection, with the examinations named there (paragraph 5), and the examinations of the inspection before commissioning are, where necessary, carried out on the modified equipment (paragraph 6).
  5. The result is paperwork: a supplement to the existing declaration, or — where paragraph 6 applies — a new declaration of commissioning (paragraph 8).

Who assesses what

In the service phase it is not the notified body. That body had its role in the CE phase and is done. Article 26(3) designates the NL conformity assessment body or the NL user inspectorate. A user's own inspection department may carry out the examinations for an intended repair, under the supervision of and in so far as certified by an NL conformity assessment body — but only for repairs, not for modifications, and the declaration stays with the body (Article 36(5) and (6)). And only that body may write on the annotation sheet accompanying the declaration of commissioning (Article 24(3)): not the user, and not you.

References: WBDA 2016 Article 21(1) (designation), Article 24(3) (annotation sheet), Article 26(1), (2), (3), (5), (6) and (8), Article 36(3), (5) and (6); WRDA 2016 Article 13 (implementing Article 26(9)) and Article 15(1)(e) and (f), where repairs and modifications are two separate designation elements. Checked 17-09-2026.

Who carries which duty — and why you are not in it

Search the Dutch pressure equipment decree for “maintenance contractor” and you find nothing. The definitions in Article 1 do not know it, and no obligation is addressed to the maintenance contractor as such. That is not an exemption but a shift: the duties sit with the user and with the manufacturer, and they reach you through your contract and through occupational health and safety law. Two provisions can reach you directly, because they are not limited to “the user”: the prohibition in Article 2(1) on using equipment that does not meet the requirements, and the duty of care in Article 20(1).

PartyWhat the decree asks of it
Usernotify the body (Art. 26(2)), request and pay for the inspections (Art. 21(2) and (3)) and keep the documents for as long as the equipment can be operated (Art. 25(3)). Two provisions that concern the user but are worded impersonally: the equipment is accompanied by instructions in Dutch (Art. 18) and the installation of CE-marked equipment is accessible for maintenance and repair among other things (Art. 19(1))
Whoever has the equipment in his possession or uses itensure it is kept in a good state of maintenance (Art. 20(1); the provision also names whoever delivers or displays it). This is the provision that comes closest to the maintenance contractor, together with the prohibition in Article 2(1)
NL body or NL user inspectoratethe assessment beforehand and the tests during the work (Art. 26(3)), and drawing up the supplement or the new declaration (paragraph 8)
Maintenance contractorthe decree does not name you. What binds you is your contract with the user, and the Working Conditions Decree as the employer of your fitters

What the Working Conditions Decree does ask of you

There you are the addressee, because those duties are addressed to the employer — including the employer of the fitter standing on someone else's site. Article 7.5(2) requires maintenance, repair and cleaning work on work equipment to be carried out only once it has been switched off and depressurised or de-energised — and, where that is not possible, that effective measures be taken so the work can be done safely. Paragraph 3 applies that same requirement to production and adjustment work. Paragraph 4 requires a maintenance log belonging to the work equipment to be kept properly. For self-employed workers paragraphs 2, 3 and 5 apply — not paragraph 4 (Article 9.5(1)(f)).

Two regimes that displace one another. Article 7.4a of the Working Conditions Decree governs the inspection of work equipment, but steps back for pressure equipment paragraph by paragraph: paragraphs 1 and 2 do not apply where Article 21 of the decree applies (paragraph 10), paragraph 3 does not where Article 22 applies (paragraph 11(d)), and paragraph 4 does not apply in respect of modifications or repairs to equipment covered by Article 22 (paragraph 12). Paragraphs 5 and 6 — inspection by an expert and the written evidence at the workplace — do not step back. So you have one inspection regime, not two — but two sources for your own way of working.
References: WBDA 2016 Article 1 (definitions), Articles 18, 19(1), 20(1), 21(2) and (3), 25(3), 26(2), (3) and (8); Working Conditions Decree Article 7.4a(10), (11)(d) and (12) (interaction with the pressure equipment decree), Article 7.5(2), (3) and (4), Article 9.1 (the employer as addressee) and Article 9.5(1)(f), which applies Article 7.5(2), (3) and (5) among others to self-employed workers. Note: Article 7.36 of that decree, on apparatus under pressure, has been repealed and is still quoted in older documentation.

Safety accessories and valves: the heaviest case

Anyone overhauling valves is working on the class the directive rated highest. Annex II, point 2 classifies safety accessories in category IV in principle. The exception there is narrow: accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.

Annex I, 2.11, sets its own design requirements for safety accessories; point 2.11.1 expressly names the requirements as to maintenance and testing of the devices. That is a requirement on the manufacturer, not on you — but it is the place where the manufacturer records what may be done to his valve. So your first question at an overhaul is not what the directive says but what the manufacturer prescribed in his instructions.

Where the source is silent

And then the point you will read nowhere else in these terms: on overhauling or re-setting a safety valve the directive and the guidelines say nothing. There is no guideline on reconditioning, on set pressure, on replacing a spring or on re-sealing. Nor is there a general guideline on spare parts in the service phase. Anyone telling you the directive has a rule here is quoting something else — usually a product standard, a client specification or a sector practice. That does not make such a rule wrong, but it does make it something other than legislation, and that difference has to be visible in your file.

Why this matters for the interval. Safety accessories follow the shortest fixed re-inspection interval of the equipment they protect (WRDA Article 5(2)), they are excluded from interval extension (Article 7(1)), and for discharging mechanical safety accessories a maximum of ten years applies where intervals are made flexible (Article 8(9)). An overhaul programme built on the vessel's interval therefore drifts out of step with the valve on top of it.
References: Annex II, point 2; Annex I, 2.11, with the maintenance and testing requirement in 2.11.1; Article 2(4) (safety accessories); WRDA 2016 Article 5(2), Article 7(1) and Article 8(9). No provision on overhauling or re-setting safety valves was found in the v6.0 bundle of guidelines.

What a repair or modification does to the inspection interval

Three effects that get forgotten in the planning.

A modification can create a duty of inspection

The designation in the Dutch regulation hangs on the Annex II table and on the category. Raise the allowable pressure, change the fluid or enlarge the volume, and the equipment can land in a different table or a higher category and become subject to inspection for the first time. A modification that looks technically small can thus produce an inspection before commissioning and a re-inspection cycle.

A completed repair can block an extension of the interval. Article 7(5)(c) of the Dutch regulation makes the extension depend on whether repairs and modifications carried out stand in its way. So anyone holding an extended interval who repairs in the meantime has to look at it again.

And for unclassified equipment the heaviest regime applies. Article 13 of the Dutch regulation implements Article 26(9) of the decree and provides that for pressure equipment not classified in accordance with Annex II, category IV is used in applying the essential safety requirements of Annex I. Old equipment from before the CE era often falls under this — precisely the equipment maintenance contractors work on most.

References: WRDA 2016 Article 2 (designation per table and category), Article 5 (fixed intervals), Article 7(5)(c) (repairs and modifications on extension), Article 8 (flexible intervals) and Article 13(1) to (3) (assessment of modification and repair, with category IV for unclassified equipment); WBDA 2016 Article 26(5), (6) and (9).

Five misconceptions, with the provision that refutes each

What gets saidWhat the text says
“After a repair the CE marking has to be affixed again”No. A repair produces no new product (guideline A-03, case 2), and Article 26(1) of the Dutch decree applies Annex I mutatis mutandis except for affixing the CE marking. The original declaration stands.
“A large repair is automatically a substantial modification”The Blue Guide looks not at size or cost but at three conditions together: changed performance, purpose or type; changed hazard or increased risk; and made available or put into service again.
“The notified body assesses our repair”Not in the service phase. Article 26(3) designates the NL conformity assessment body or the NL user inspectorate; the notified body had its role in the CE phase.
“As a maintenance contractor we have no duties under the pressure equipment decree”The decree does not name you, but Article 2(1) and Article 20(1) are not limited to the user and can therefore reach you. And beyond that: the duties sit with the user, but your contract puts them on you, and the Working Conditions Decree binds you directly as an employer (Article 7.5 and Article 9.1).
“Notifying afterwards is fine”Article 26(2) says without delay, and paragraph 3 has the body assess the design and construction of the intended modification or repair. Notifying afterwards means there is nothing left to assess in advance.

Frequently asked questions

Does a repair of pressure equipment fall under the PED?

No. PED guideline A-03 says so in as many words: repairs are not covered by the directive but by national regulations, if any. In the Netherlands there are such rules for equipment subject to inspection: Article 26 of the pressure equipment decree 2016 applies Annex I mutatis mutandis — except for affixing the CE marking — has the body notified without delay, and has the intended repair assessed beforehand. Where your equipment is not designated, that regime does not apply and what remains is the general duty of care in Article 20 and the Working Conditions Decree.

When does a modification become a new product with a new CE marking?

Where three things hold together, according to Blue Guide 2022 § 2.1: the original performance, purpose or type changes in a way not foreseen in the initial risk assessment; the nature of the hazard changes or the level of risk increases; and the product is then made available on the market or put into service. Whoever carried out the modification then performs a new conformity assessment, draws up a new EU declaration of conformity and affixes the CE marking in his own name. It is not the size of the job that decides, but whether the equipment has become something else.

Does our maintenance company then become the manufacturer?

On a substantial modification: yes. Article 2(18) of the directive calls a manufacturer whoever manufactures pressure equipment or has it manufactured and markets it under his own name or uses it for his own purposes. That definition looks at the act, not at your line of business or your contract. On a repair you do not become the manufacturer, because no new product arises. The line between those two is therefore the most important question you answer before the work, and record in writing.

May our own inspection department assess the repair?

Only the examinations, and only for repairs. Article 36(5) of the Dutch decree lets a user’s inspection department carry out examinations within periodic re-inspections and within intended repairs, under the supervision of and in so far as certified by an NL conformity assessment body. Modifications fall outside that, and the declaration is drawn up by the body in any event (paragraph 6). The department may also not be responsible for the maintenance itself (paragraph 3).

What applies to overhauling a safety valve?

The directive and the guidelines say nothing about it: there is no provision on reconditioning, set pressure, spring replacement or re-sealing. What is settled is the weight of the object — Annex II, point 2, classifies safety accessories in category IV in principle — and the interval: they follow the shortest fixed re-inspection interval of the equipment they protect (WRDA Article 5(2)), are excluded from interval extension (Article 7(1)) and, where intervals are made flexible, carry a maximum of ten years for discharging mechanical accessories (Article 8(9)). So your method comes from the manufacturer’s instructions and from the product standard, not from the directive.

Not sure whether this work is still a repair?

That is exactly the question the classification appraisal was made for: your case worked through, the reading chosen with the provision next to it, and a signed opinion you can hand to your client or to the body.

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