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.
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.
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.
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.
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.
The review comes first. The drafts follow from what it finds.
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.
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.
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.
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.
A sample of the written findings you receive.
| 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 |
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.
One price per product family, paid before the review starts.
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.
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.comWrite in English or Chinese.