Sell your U.S.-built machines in Europe without the compliance detour
U.S. manufacturers come to us when a European customer asks for “the CE certificate” and the Declaration of Conformity. We run the risk assessment, build the technical file, and deal with the Notified Body when there is one — with EU safety engineers, under a contract with our U.S. entity in New York.
- EU-established entity — Advolo srl, Italy
- U.S. contracting entity — New York
- Machinery · ATEX · PED · Functional safety
- Both directions: EU market access and U.S. market access
Your control panel is UL 508A listed and your machine is built to NFPA 79. In Europe, that is not by itself evidence of conformity.
There is no “CE certificate” to buy. CE marking is a declaration you sign, under your own responsibility — and Europe holds you to it. U.S. manufacturers usually discover this when a customer in Germany or Italy asks for the Declaration of Conformity, weeks before shipping.
What actually blocks the shipment:
- No risk assessment on file. The technical file has to contain it (Directive 2006/42/EC, Annex VII, A.1(a)), and it is the first document anyone asks for in a dispute.
- No technical file — and it has to stay available to EU authorities for ten years (Annex VII, A.2; from 2027, Regulation (EU) 2023/1230, Article 10(3)).
- No economic operator established in the Union. Regulation (EU) 2019/1020, Article 4: a machine may be placed on the EU market only if one exists.
- A control panel documented to NFPA 79 and UL 508A, with nothing in the file that demonstrates conformity with EN 60204-1. Some requirements coincide — but the coincidence has to be demonstrated, not assumed, and that work has to be done before the machine ships.
What we do
- CE marking, end to end From risk assessment to the CE mark on the plate Read the page
- Machinery Regulation 2023/1230 What changes on 20 January 2027 Read the page
- Technical file & Declaration of Conformity The two documents your EU customer will ask for Read the page
- Do you need a Notified Body? Usually not. Here is how to know Read the page
- ATEX Equipment for potentially explosive atmospheres — Directive 2014/34/EU Read the page
- Functional safety ISO 13849 or IEC 62061 — PL or SIL Read the page
Engineered in Europe. Contracted in New York.
- 1.Route review. Send us the machine and the destination market; we come back with which directives apply and whether a Notified Body is involved.
- 2.Risk assessment. On your drawings, with our engineers in Italy.
- 3.Technical file. Built once, reused for every machine in the family.
- 4.Declaration of Conformity. You sign it. We make sure it holds up.
- 5.EU authorised representative. Advolo srl acts as your authorised representative in the Union, under a written mandate: it holds your Declaration of Conformity and technical file and produces them for the authorities on a reasoned request.
Based in Europe and selling into the United States? That is the other direction we work in — NFPA 79, UL 508A, NRTL listing and field evaluation, OSHA and ANSI B11, all the way to the Site Acceptance Test.
U.S. market access-
U.S. compliance NFPA 79 and EN 60204-1: where a European panel stops being compliant
IEC 60204-1 publishes in its own front matter a clause-by-clause list of the differing practices that apply in the United States.
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U.S. compliance UL 508A: why a compliant European panel is rejected in the United States
Not because it is badly built. The two systems prove safety in different directions.
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U.S. compliance NRTL listing, field evaluation, and the one-off machine
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U.S. compliance FDA laser product registration for machine builders
If your machine contains a laser, a second American regime applies — and unlike everything else on this site, this one is addressed to you. It has a customs check, and non-compliant goods are refused entry.
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U.S. compliance SEMI S2 and S8: the requirement that arrives in the purchase order
A voluntary industry guideline that behaves exactly like a mandatory requirement — because it reaches you through the contract instead of through the law. That difference decides who you argue with when there is a disagreement, and it is worth understanding before you sign.
How to check what we tell you
When this site states a legal requirement, it gives you the reference it rests on — the article of the directive or regulation, or the federal rule if it is American. Not “industry best practice”, not “as you know”: the reference, so you can open the text and read it yourself.
We do that for a practical reason. In this market a supplier’s technical claim is usually impossible to verify before you have paid for it, and the cost of a wrong one lands on the manufacturer who signed the declaration — not on the consultant who drafted it.
Two examples you can check right now:
Fact — check it yourself
The Regulation’s date of application was published wrong in the Official Journal — 14 January 2027 — and corrected to 20 January by a corrigendum.
The uncorrected date is still circulating in files served today by the EU’s own legislation portal.
Reg. (EU) 2023/1230, art. 51(2) · corrigendum OJ L 169/35, 4.7.2023
Fact — check it yourself
“Annex IV means you need a Notified Body” is false.
Article 12(3)(a) allows self-assessment for Annex IV machinery built fully to harmonised standards that cover all the relevant health and safety requirements — miss that second condition and you are in Article 12(4), where a Notified Body is required. It is the most expensive misunderstanding in this market, and it is repeated by people who sell certification.
Directive 2006/42/EC, art. 12(3)(a), 12(4)
Questions we get asked before the first call
Who issues the CE certificate for machinery?
Nobody — there is no such document. You affix the marking and you sign the EU Declaration of Conformity yourself (Directive 2006/42/EC, Annex II, 1.A.10).
Do I need a Notified Body?
Usually not — under the Directive in force today, only if your machine is on the Annex IV list and the harmonised standards you built to do not cover every relevant health and safety requirement. From 20 January 2027 six categories need one whatever standards you built to.
Can we self-certify?
For most industrial machinery, yes — and it is the normal route, not a shortcut or a loophole.
Our panel is UL 508A listed and built to NFPA 79. Does that count in the EU?
Not by itself. Europe asks different questions about electrical equipment and answers them through EN 60204-1. The delta is a defined engineering task, and it has to be closed before shipping.
What goes in the technical file, where do we keep it, and for how long?
Ten years, and it does not have to sit in Europe or on paper — but it has to be assembled and produced on a reasoned request from a national authority (Annex VII, A.2).
Tell us the machine and where it is going
We will come back with the route: which directives apply, whether a Notified Body is in the loop, and which of your existing documents already count as evidence. If the answer is “you need less than you think”, that is what you will hear — we do not issue certificates, so whether you need one is decided by the directive, not by us.