We review your PPE documents against EU rules — and draft what is missing.

You get a gap report that lists what is present, what is missing and what has to be redone. We draft the corrections, and you review and issue them as the manufacturer.


What we review today

Arulero AS is established in Norway, in the European Economic Area. We review product documentation against the EU requirements that apply to personal protective equipment, and we draft what is missing for the manufacturer to issue.

The work is the same whichever way your goods reach the market: an importer or wholesaler in the EU has asked for your file, a marketplace has asked for your documents, or a new model or a new country has made the question live. Send what the request names and what you already hold.

Right now we review personal protective equipment. Typical examples are shown below. PPE category is determined by the protective function and the risks claimed for the specific product, not by the product name alone. The same glove can fall in a different category depending on what it is sold as protecting against.

PPE Category I

Internal production control (Module A). No notified body involvement.
  • Non-prescription sunglasses (sun and UV eye protection)
  • Gardening and general-handling gloves
  • Gloves against weak cleaning agents
  • Simple rainwear for non-extreme conditions
  • Thimbles

PPE Category II

EU type-examination (Module B) plus conformity to type based on internal production control (Module C). Unlike Category III, Category II does not require ongoing notified-body production surveillance.
  • Safety footwear
  • Work gloves
  • Bicycle, ski and skate helmets
  • High-visibility clothing
  • Sports shin guards and protectors
  • Impact eye and face protection

We do not review Category III PPE. Category III is the regulation's closed list of risks that may cause death or irreversible damage to health. PPE in that category includes respiratory protection, fall-arrest PPE, lifejackets, hearing protection, PPE against hand-held chainsaw cuts and certain PPE against extreme heat. It adds ongoing notified-body involvement in production (Module C2 or Module D) on top of the type-examination, rather than a single examination.

Your product is not on this list? Write anyway. Tell us what it is and where it ships from, and we will say plainly whether we can review it.


Our Services

1. Document review

We check your product's documents against the EU requirements that apply to it: the EU Declaration of Conformity against Annex IX of Regulation (EU) 2016/425, the test reports against the harmonised standard cited and its edition, the model designation across every document, the notified body's number and scope in the NANDO register and the validity dates of the type-examination certificate for Category II, the label and the instructions against what they have to carry and the languages they have to carry it in, and relevant REACH restrictions based on the product and material information supplied.

You receive a gap report. Every finding is marked present, missing or redo, with the required action and with what the finding rests on: the regulation, the guidance or the standard clause behind it, or our own assessment where it turns on classification or intended use. The findings are produced by our AI review engine against the cited law. We issue no certificates and run no tests.

2. Document preparation

Where the review finds a document missing or wrong, we draft the correction for you: an EU Declaration of Conformity with the content Annex IX requires, user instructions and safety information in the languages of the markets you sell in, label text, and a risk analysis for the technical documentation. You review the drafts, sign the Declaration of Conformity and issue the documents as the manufacturer.

The manufacturer draws up the technical documentation under Article 8 of the Regulation; we draft parts of it, and nothing we draft moves that responsibility. Re-testing, re-labelling and re-issuing are done by you and your suppliers. We say what has to be done and why.

We do not act as your authorised representative, and we do not act as a Responsible Person.

Arulero holds no economic-operator role for any client. Whether your goods need an operator established in the EU depends on the law and on how they reach the market; the answer is under FAQ. The documents are yours to issue and the product is yours to place on the market. What we deliver is the review and the drafts.


How it works

The review comes first. The drafts follow from what it finds.

  1. 1

    Send product details and documents

    Whatever exists: product description, EU Declaration of Conformity, test reports, type-examination certificate, datasheets, instructions and packaging artwork. If an importer or a marketplace has asked you for something, send their request too.

  2. 2

    Review

    Declaration of Conformity, test reports, the harmonised standard cited and its edition, the notified body and certificate for Category II, relevant REACH restrictions based on the product and material information supplied, and what the label and instructions have to carry.

  3. 3

    Written gap report

    What is present, what is missing, what has to be redone. Each finding states what it rests on: the regulation, guidance or standard clause behind it, or our assessment where it turns on classification or intended use.

  4. 4

    Corrections drafted

    We draft the missing or corrected documents. You review and issue them as the manufacturer, and carry out any re-testing or re-labelling the report calls for.

What you get from us

A sample of the written findings you receive.

Product
Safety glove
Category
PPE Category II
Scope
Declaration of Conformity and technical documentation
Status
Illustrative sample
Technical file review — sample findings
Status Finding Required action What it rests on
Present Declaration of Conformity, point 2: the manufacturer's name and address are given. Keep the current version with the technical documentation. Regulation (EU) 2016/425, Annex IX, point 2
Missing User instructions are not supplied in the languages of the markets the product is sold in. Add instructions in the language each market requires. Regulation (EU) 2016/425, Article 8(7) and Annex II, point 1.4
Redo Test report cites EN 388:2016, withdrawn from the Official Journal list on 19 November 2021. Re-test to the listed edition, or justify the cited edition against it. Regulation (EU) 2016/425, Article 14 and the Official Journal list of harmonised standards
Missing Neither the glove marking nor the packaging artwork carries the manufacturer's postal address or a batch identifier. Add both to the artwork before placing on the market. Regulation (EU) 2016/425, Article 8(5) and 8(6)
Redo Technical documentation does not clearly link the model variants. Clarify the model-family structure. Our assessment — classification of the model family
Present
Required information found in the supplied documents
Missing
Required items not provided
Redo
Items that must be corrected

A review of documents is not a conformity assessment. The product is what conforms, and the EU Declaration of Conformity is the manufacturer's. Our report says what the documents support and what they do not, with what each finding rests on, and the documents we draft are yours to issue.


Price

One price per product family, paid before the review starts.

Review of one product family
from €59
Each further language of the drafts
€9 per language per product family

A product family is a group of related models and variants from one manufacturer that share an intended use, a construction and materials, and the requirements that apply. We confirm the family scope and exact price with you before the review starts and before you are charged. The rate falls with the number of families reviewed in the past twelve months. Prices are in euro and exclude VAT. We sell to businesses only.

The price covers the gap report and the drafts the report calls for, in English: the EU Declaration of Conformity, the instructions and safety information, the label text and the risk analysis, for you to review and issue as the manufacturer. Re-checks of the same product family, after you have corrected or added documents, are included as long as you keep a prepaid balance of at least €49.

The gap report comes as a PDF, in English. The drafts come as editable files: DOCX for the Declaration of Conformity and for the instructions and safety information, and PDF with the marks as vector files for the label text. An incomplete set is reviewed as it is: the report names what is missing, and what you find later goes in as a re-check.


Frequently Asked Questions

Do we need an EU authorised representative?
Not because of the PPE Regulation. Article 9 of Regulation (EU) 2016/425 says a manufacturer may appoint one by written mandate: an operator established in the EU that keeps the Declaration of Conformity and the technical documentation at the disposal of market-surveillance authorities, provides information on reasoned request and cooperates on corrective action. It is not a role every supply chain has to fill. The requirement that can apply is Article 4 of Regulation (EU) 2019/1020: PPE may be placed on the EU market only if an economic operator established in the EU is responsible for the tasks that Article sets out, and that operator can be a manufacturer established there, an importer, an authorised representative holding a written mandate, or, where none of those exists, a fulfilment service provider. If an importer established in the EU places your goods on the market, the importer meets it. If you sell direct, through a marketplace or your own site, with no such operator, you need one. We are not that operator, and we do not arrange one. What we do is review and draft the documents that importers, marketplaces and authorities ask for.
Are you a notified body or a test laboratory?
No. We issue no certificates and run no tests. We read the laboratory's test report and check whether the tests performed, the methods used, the edition of the standard applied and the results actually support the product's Declaration of Conformity.
Can you get us a "CE certificate"?
There is no such document to get. CE marking is affixed by the manufacturer on the basis of its own declaration that the product conforms. It is not a certification granted by an EU body. What genuinely exists is a Declaration of Conformity, a technical file, and — for Category II and Category III — an EU type-examination certificate issued by a notified body, whose reference Annex IX requires in the Declaration where applicable. So if you hold a type-examination certificate, it is real and it matters. What does not exist is a single document called a "CE certificate" that confers the marking. If someone offers you a generic "CE certificate" as proof of the marking, they are at minimum confusing the CE marking with the conformity assessment documents that actually exist.
Can you be our GPSR Responsible Person?
No. We do not act as Responsible Person under the General Product Safety Regulation, and we hold no other economic-operator role. If a marketplace has asked you for a Responsible Person, that is an appointment you make elsewhere. If it has asked you for documents, that is the work we do.
Does the review cover extended producer responsibility?
No. Those are separate obligations. Packaging, batteries, electronics and other product streams can trigger separate EPR registrations and, in some countries or regimes, a separate EPR authorised representative — the Batteries Regulation defines that role expressly, and WEEE provides a mechanism for it in Article 17. Where your documents show a likely obligation we say so. Registering, or appointing a representative for it, remains yours to do, and we do not hold that role.
Who signs what you draft?
You sign the Declaration of Conformity, and no one signs the rest. Under Article 8 of the PPE Regulation the manufacturer draws up the technical documentation, and under Article 15, by drawing up the EU Declaration of Conformity, the manufacturer assumes responsibility for the product's compliance. We draft the Declaration, the instructions, the label text or the risk analysis for you to review. The Declaration is the one document that carries a signature, and you sign it as the manufacturer. The instructions go with the product, the label text goes on it and the risk analysis goes into the technical documentation, none of them signed. Signing the Declaration does not move that responsibility to us.

Contact us

Describe the product and where it ships from, and tell us who asked for the documents, if anyone has. Attach whatever you have — an incomplete set is normal and is exactly what the review is for.

company@arulero.com

Write in English or Chinese.