Notified Body · No. 2233

CE Certification for Personal Protective Equipment (PPE)

EU type-examination and production surveillance under Regulation (EU) 2016/425 — helping PPE manufacturers worldwide obtain the CE mark.

Category II and III PPE require an EU type-examination by a notified body; Category III also requires notified-body oversight of production (Module B + C2/D).

Without the CE mark, PPE cannot lawfully be placed on the EU/EEA market.

The CE mark is your product’s passport to the EU/EEA single market — a precondition for sale and a mark of trust that makes it commercially viable.

What you receive

GÉPTESZT is an EU notified body (No. 2233) that helps personal protective equipment manufacturers worldwide obtain the CE mark under Regulation (EU) 2016/425. We focus on high-risk Category III PPE. EU type-examination rests on examining the technical documentation and testing representative samples; the required tests are run in our own ISO/IEC 17025 laboratory, drawing on cooperating laboratories where needed.

Is your PPE Category III?

PPE is classified by the risk it protects against. Category III covers the most serious hazards and always requires a notified body — for both the type-examination and production. It comprises exclusively the risks that may cause death or irreversible harm:

Source: Regulation (EU) 2016/425, Annex I, as reproduced in the European Commission’s PPE Regulation Guidelines. Category I covers minimal risks (self-certified by the manufacturer); Category II is everything not in Category I or III.

Conformity assessment modules under Regulation (EU) 2016/425

The route to CE marking depends on the PPE risk category. For Categories II and III a notified body — GÉPTESZT (NB 2233) — must be involved; for Category III, throughout production.

Category I Low risk

E.g. superficial mechanical injury, mild cleaning agents — gardening gloves, sunglasses.

AInternal production control

The manufacturer ensures and declares conformity itself. (Annex IV)

No notified body required.

Category II Intermediate risk

Everything not in Category I or III — e.g. general protective gloves, high-visibility clothing, head protection.

BEU type-examination

A notified body examines the documentation and tests a representative sample. (Annex V)

CConformity to type

The manufacturer ensures series production conforms to the type (internal production control). (Annex VI)

Category III Serious / irreversible

E.g. fall protection, respiratory, chemical and high-voltage risks — GÉPTESZT’s core area.

BEU type-examination

Examination of the documentation and testing of a representative sample. (Annex V)

Production surveillance — one module

C2Supervised product checks

At random intervals, by a notified body. (Annex VII)

or
DQuality assurance of production

Assessment and surveillance of the manufacturer’s quality management system. (Annex VIII)

Notified body — GÉPTESZT (NB 2233) Manufacturer

As notified body NB 2233, GÉPTESZT performs Module B (EU type-examination) and the Category III production modules (C2 and D). Source of the module scheme: Regulation (EU) 2016/425, Article 19.

The competencies behind a CE certificate

A notified body isn’t a single activity — conformity assessment is built from several distinct competencies, each defined by its own international standard, and different PPE modules draw on different ones.

EN ISO/IEC 17025

Testing

Carrying out the physical tests on samples.

Type-examination & product checks

EN ISO/IEC 17065

Product certification

Making the conformity decision and issuing the certificate.

Module B

EN ISO/IEC 17020

Inspection

Supervised product checks at random intervals.

Module C2

EN ISO/IEC 17021‑1

Quality-system auditing

Assessing the manufacturer’s production quality system.

Module D

Where GÉPTESZT fits. The standards above describe these competencies in general. GÉPTESZT performs Modules B, C2 and D as notified body 2233 under Regulation (EU) 2016/425 — its conformity-assessment competence conferred and supervised by the national designating authority, which verifies that it meets the Article 24 requirements these standards are built to demonstrate — with testing carried out in its in-house ISO/IEC 17025 laboratory. The notification is verifiable in the EU NANDO database.

The certification journey with GÉPTESZT

From classification to CE mark — GÉPTESZT performs every notified-body step and guides you through the rest.

  1. 1

    Classify the PPE

    Determine the risk category (I, II or III) under Annex I — this sets the entire route to CE marking.

  2. 2

    Compile the technical file

    Design, risk assessment, applicable requirements, standards applied and test evidence (Annex III).

  3. 3

    EU type-examination (Module B)

    GÉPTESZT examines the technical documentation and tests representative samples of the PPE type against the requirements and harmonised standards, then issues the EU type-examination certificate — required for Category II and III.

  4. 4

    Production control (Module C2/D)

    For Category III: ongoing GÉPTESZT oversight — supervised product checks at random intervals (C2) or quality-system surveillance (D).

  5. 5

    CE marking

    You draw up the EU Declaration of Conformity and affix the CE mark, followed by our notified-body number, 2233 (for Category III).

What GÉPTESZT is designated for

Our notified-body scope, with the module path we run for each area:

Fall protection

Category III

Module B + C2/D

Industrial fall-arrest systems and mountaineering PPE — full-body harnesses, lanyards, energy absorbers, connectors, anchor devices and rope-adjustment systems.

Respiratory protection

Category III

Module B + C2/D

Filtering half masks against particles (EN 149) and filtering half masks without inhalation valves (EN 1827).

Head protection

Category II

Module B (EU type-examination)

Industrial safety helmets, bump caps and mountaineering helmets. As Category II PPE these need EU type-examination — production control (Module C) stays with the manufacturer.

Safety footwear & gloves (Cat III)

Category III

Module C2/D

Production surveillance for Category III safety footwear and protective gloves. Our local auditors keep travel-related costs low.

What you provide: documentation and samples

EU type-examination rests on examining the technical documentation and testing representative samples — so we ask for both. Under Annex III the documentation includes at least:

Alongside the documentation we also ask for representative samples (specimens) of the PPE — partly for laboratory testing, partly for the assessment. The notified body may request further specimens to carry out the test programme (Annex V).

Source: Regulation (EU) 2016/425, Annex III. GÉPTESZT helps you compile and complete the file.

Practical advantages for manufacturers

GÉPTESZT applies the Regulation the way the notified bodies have agreed to interpret it (the Recommendations for Use) — which turns into concrete savings in cost, time and risk for you.

Remote production checks (Module C2)

Where it is risk-appropriate, we can carry out Module C2 product sampling remotely by video. The Regulation obliges notified bodies to avoid unnecessary burdens on manufacturers (Article 32(2)) — so you save the travel and on-site cost of surveillance and it happens faster.

We build on your existing test data

Whether existing test data can replace a repeat test is a conformity-assessment decision — so it rests with the notified body, not the test bench. We can accept accredited test reports, and, where a test falls outside an accredited scope, data we verify against the applicable ISO/IEC 17025 requirements. Any testing we run ourselves is done in our in-house ISO/IEC 17025 laboratory. Whether the data is a subcontracted lab’s or ours, the notified body reviews it and takes full responsibility for what it accepts (Article 26). Fewer repeat tests, a faster route to your certificate.

We assess foreseeable use — not just the claimed use

If a product’s design could be read as protecting against a use it does not actually cover, a warning in the manual is not enough under the Regulation. We flag it during type-examination and guide the design or marking fix — so your PPE does not run into a market-surveillance problem after launch.

Why GÉPTESZT?

An EU notified body since 2009, with our own testing laboratory and auditors close to your production — so certification is thorough, fast and cost-efficient.

EU PPE emblem

GÉPTESZT is an active member of the PPE Notified-Bodies coordination — the Horizontal Committee and the relevant Vertical Groups — the forum that develops the Recommendations for Use (RFUs) that harmonise how the PPE Regulation is applied across the EU.

One laboratory, two capacities. Our testing laboratory is physically a single unit: within our notified-body scope we run the tests required for EU type-examination, and under ISO/IEC 17025 accreditation we test to other standards (for example ANSI) and non-PPE items — so testing for the EU and for international markets can be done in one place.

2009

Notified Body since

NB 2233

verifiable in NANDO

200+

manufacturers supported

~40

countries

  • ✓In-house ISO/IEC 17025 testing laboratory — in both notified and accredited capacities.
  • ✓Local auditors worldwide — lower travel and audit costs.
  • ✓Independent, impartial conformity assessment.
  • ✓Notification verifiable in the EU NANDO database.

Frequently asked questions

Do I need a notified body for my PPE?▾
For Category II and III PPE, yes — an EU type-examination (Module B) by a notified body is mandatory before the product may be placed on the market. Category III additionally requires notified-body oversight of production (Module C2 or D). Category I PPE is self-certified by the manufacturer, with no notified body.
Does it matter whether I am established inside or outside the EU?▾
Your obligations as the manufacturer — conformity assessment (Module B, plus C2/D for Category III), technical documentation, the EU Declaration of Conformity and the CE marking — are the same wherever you are established, so GÉPTESZT’s certification is identical. What differs is market placement: a non-EU manufacturer needs an EU-established importer, who must ensure the conformity assessment was carried out and whose name and address appear on the product, and may appoint an EU authorised representative. Under Regulation (EU) 2019/1020 there must also be an economic operator established in the EU whose details are on the product.
I sell PPE under my own brand but it is made by another factory (OBM / private label) — who is the manufacturer?▾
You are. Under Article 12 of Regulation (EU) 2016/425, anyone who places PPE on the market under their own name or trademark — or modifies PPE so that compliance may be affected — is considered the manufacturer and takes on all manufacturer obligations, including the conformity assessment. You cannot rely on the original maker’s certificate issued under a different brand; the PPE must be certified for your product and brand. GÉPTESZT can carry out that assessment.
What is the difference between Module C2 and Module D?▾
Both are production-phase modules for Category III PPE. Module C2 (Annex VII) is conformity to type based on internal production control plus supervised product checks at random intervals. Module D (Annex VIII) is conformity to type based on quality assurance of the production process, where the notified body assesses and monitors your quality-management system. You choose one; GÉPTESZT is designated for both.
How long is an EU type-examination certificate valid?▾
The period of validity of a newly issued or renewed EU type-examination certificate does not exceed five years (Regulation (EU) 2016/425, Annex V). It must be reviewed when the state of the art or the applicable harmonised standards change.
My product has a certificate under the old PPE Directive 89/686/EEC — is it still valid?▾
No. EC type-examination certificates issued under Directive 89/686/EEC ceased to be valid on 21 April 2023. PPE placed on the market must now be certified under Regulation (EU) 2016/425.
What does the number after the CE mark mean?▾
For Category III PPE, the CE mark is followed by the four-digit identification number of the notified body responsible for the production-control phase. GÉPTESZT’s number is 2233 — it tells the market and the authorities which body oversees the ongoing conformity of your product.
What do I need to submit for certification?▾
Two things. First, the technical documentation set out in Annex III: a description of the PPE and its intended use, a risk assessment, the applicable essential health and safety requirements, design and manufacturing drawings, the harmonised standards applied, test reports, and the user instructions. Second, representative samples (specimens) of the PPE — partly for laboratory testing, partly for the assessment; the notified body may request further specimens to carry out the test programme (Annex V). GÉPTESZT guides you through compiling and completing the file.
Can you also test to non-EU standards, for example ANSI?▾
Yes. Our testing laboratory is physically one unit but operates in two separately supervised capacities. Within our notified-body scope we perform the testing for EU type-examination under Regulation (EU) 2016/425 (supervised by the notifying authority); under our ISO/IEC 17025 accreditation (supervised by the national accreditation authority, NAH) we perform testing that is not an EU PPE requirement, or not PPE at all — for example testing to ANSI standards. We do not use the notified status for work outside the EU requirements. This lets EU and international testing be done in one place, with a single partner.
My product combines a Category II item with a Category III accessory (e.g. a helmet with mounted earmuffs) — does the whole assembly need a notified body?▾
No. Only the Category III part is subject to production surveillance (Module C2/D) and carries the notified body number. The finished assembly then bears two CE marks — one followed by the notified body number (for the Category III part) and one without it (for the Category II part).
My PPE carries more than one company name or trademark — how must they be labelled?▾
Each operator’s role must be clear on the product, packaging or accompanying documents: the manufacturer identified as "made by" or "manufactured by", an importer as "imported by". The technical documentation must record the relationships and a written authorization for each name used, and any name variations must appear on the EU type-examination certificate.
Can one EU type-examination certificate cover several products?▾
Yes. Two or more products placed on the market independently can share a single EU type-examination certificate, provided the certificate is clear and each PPE is fully described as required by Annex V.
Can I use one "universal" instruction manual for several PPE products?▾
Yes. A manufacturer can draw up one set of documented instructions covering several PPE, provided each product is clearly linked to its instructions, the risks the PPE protects against and the limits of use are identified, and the notified body’s name is clearly tied to the products it actually assessed.
Can I put the ATEX marking on my PPE?▾
No. PPE is excluded from the ATEX Directive (2014/34/EU), so declaring ATEX compliance or using the ATEX symbol on PPE is a misleading marking, forbidden under Article 17. The design must meet Annex II §2.6 for explosive atmospheres; the term "ATEX" may still appear in the model reference or the information for use.

Legal background

Links point to the current official text; the Hungarian decrees are available in Hungarian only.

Ready to CE-mark your PPE?

Tell us your product and its risk category — we’ll map the exact route (Module B, C2/D) and give you a clear quote.

Request a quote nb2233@gepteszt.hu