Regulatory consulting for personal protective equipment.
Classification, technical documentation, sourcing and the preparation of conformity assessment under Regulation (EU) 2016/425. For everyone placing PPE on the EU single market, from the first concept to CE certification.
Four roles, four sets of obligations
Manufacturer
You manufacture PPE, or have it designed and manufactured, and market it under your own name. Conformity assessment, technical documentation and CE marking are yours.
View obligations →Importer
You place PPE from a third country on the Union market. You must verify that the manufacturer has met their obligations. An existing CE marking is not enough.
View obligations →Distributor
You make PPE available without being the manufacturer or importer. Marking, instructions and traceability have to be checked before the sale, not after.
View obligations →Authorised representative
You act within the Union on the basis of a written mandate. What that mandate covers, and what it does not, decides your liability in a dispute.
View obligations →Not sure which role applies to you?
That is the normal case. Many companies hold several roles at once without knowing it. Anyone marketing imported goods under their own brand is treated as the manufacturer under Article 12 and carries full responsibility for a product they never designed. The same applies to anyone modifying a product already placed on the market.
Without completed CE certification your goods will not enter the single market. Anyone can print the CE symbol onto a label. What counts is the procedure behind it: classification, technical documentation and, from category II upwards, EU type-examination by a notified body.
If your European buyer places the goods on the market under their own brand, Article 12 makes them the manufacturer, carrying full responsibility for a product they did not design. Supply relationships break down at exactly this point, usually once the goods have already been produced.
Clarifying the route to conformity before series production makes the sale easier. Documents and video calls, in English or German, regardless of time zone.
The six questions economic operators start with
The Regulation answers all of them, just not at first glance. Short, and without legal jargon:
Does my PPE have to be tested at all?
Yes, in practice always. Personal protective equipment falls under Regulation (EU) 2016/425 as soon as it is intended to protect against health or safety risks. Exemptions are rare and have to be justified.
What is standards testing, exactly?
Your product is tested against the requirements of a harmonised standard: mechanically, chemically, depending on the product. Only the test result shows whether it meets the essential health and safety requirements of the Regulation.
How do I find the right notified body?
Not every notified body tests every product. What matters is the scope of its accreditation and its experience with comparable products. Both can be clarified in advance rather than regretted afterwards.
What exactly is tested against?
First the applicable risk category under Annex I, then the relevant harmonised standard. Where no suitable standard exists, the essential requirements have to be demonstrated by other means.
Which documents do I have to produce?
The technical documentation under Annex III, from the risk assessment to the EU declaration of conformity. The substantive benchmark is the essential requirements of Annex II. The scope depends on the risk category, but it is always more specific than most people expect.
What are my rights and obligations as a manufacturer?
Anyone placing a product on the market under their own name carries the full manufacturer's responsibility under Articles 8 to 12, including for bought-in goods and relabelling. That covers market monitoring and recall obligations.
This is exactly where the consulting starts: from the first product idea to certified PPE.
Book an initial callFive steps, fixed order
How long it takes depends on the product and on the workload of the notified body. The order does not.
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01
Initial call 30 minutes, free of charge
You describe the product and where you stand. Afterwards you know which risk category it is likely to fall into, which conformity assessment procedure applies and where the pitfalls are. By video call, in English or German.
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02
Conformity check
Written classification under Annex I, determination of the procedure, research into the relevant harmonised standards. You receive a roadmap with effort, estimated cost and a timeline, including the fees of the notified body, which are paid directly to them.
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03
Documentation and samples
Building or reworking the technical documentation under Annex III, risk assessment, marking and user information. In parallel, selecting the notified body and, where needed, finding a suitable manufacturing site.
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04
EU type-examination
The application is submitted by you or your manufacturer. Preparing the documentation and handling the queries happens here. Rounds of questions are the norm, not the problem. They only cost months when nobody is prepared.
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05
CE certification and market access
Once the notified body has issued its certificate: EU declaration of conformity under Annex IX.
From that point the product may be placed on the market.
Conformity assessment itself is carried out exclusively by a notified body. Step 4 describes preparation and support, not the examination.
Clearly defined packages, fixed scope
Twelve items, each bookable on its own. No open-ended timesheet.
Technical documentation under Annex III
Producing the complete documentation, or checking existing documentation against Annexes II and III before it goes to the notified body. Risk assessment, list of standards, test evidence, marking and user information. For existing documentation, delivered as a prioritised list of findings with concrete proposals for correction.
Preparation of the EU type-examination
Agreeing the scope of testing, sample selection, schedule and cost plan. Including support through every round of queries and corrections up to the certificate.
Selecting the notified body
Not every notified body is notified for every product, and the differences in scope, turnaround time and fees are considerable. The selection is made from knowledge of how these bodies work, not from a list.
Conformity check
Does your product fall under 2016/425? Which risk category, which conformity assessment procedure, which standards apply? Delivered as a structured short report with a cost estimate.
Certification strategy
Which route to the certificate is the cheapest? Procedure, scope of testing, choice of notified body and the order of the steps are connected. This decision is made at the start and sets the cost frame for the entire procedure.
Development support
Design requirements in line with the standard, and test planning, before the first prototype exists. A fault found at this stage costs a fraction.
Technical product concept
Developing the design principle, material selection and function, set out in a concept description with sketches. For companies with a product idea but without a development department familiar with the standards.
Sourcing and manufacturer introduction
Finding and assessing suitable manufacturing sites, comparing specifications and existing certificates, checking the evidence. So that the supply chain supports what is declared at the end.
Manufacturer coordination
Ongoing communication with the manufacturing site throughout the project, coordination of sample approvals and support for quality control before series production.
Products without a harmonised standard
Where no harmonised standard exists for your product, the essential requirements have to be demonstrated by other means. There is hands-on experience with exactly these test bases.
Second opinion in a crisis
Dossier rejected, or an objection from market surveillance? A rejection is an interim result, not an end point. Analysis, assessment of the prospects, action plan. Available at short notice.
Training
Half-day or full-day workshop on the PPE Regulation for development, quality assurance, purchasing and sales. By video call, in English or German.
Graphic design for marking, instructions & packaging
Compliant with the standards and properly designed, from the same hand as the consulting.
More on this → ReferenceOver 60 standards in view
Four categories tested in person, plus an overview of further PPE standard families.
To the standards overview →
From design to certificate, one point of contact
Joshua Reitmeier · Consulting on CE certification of personal protective equipment
From 2018 to 2026 I worked at a notified body as a technical expert for personal protective equipment, and from 2024 to 2026 as technical head of the PPE laboratory. I built up test facilities and carried out testing under my own release authority. Hundreds of conformity dossiers passed through my hands, which I reviewed, prepared for certification and reported on.
My area of responsibility also covered compliance with ISO/IEC 17025 and the preparation of internal and external audits. The quality logic of a test house is therefore familiar to me not only from applying it, but from being accountable for it.
Alongside that, from 2020 to 2026 I contributed to standardisation work as a member of a DIN standards committee. Standards are familiar to me not only in their application, but in how they come about.
I think about consulting from the manufacturing side. My route led from metal cutting through the state-certified engineering technician in mechanical engineering to the certified technical business administrator. That is why I assess not only whether a requirement is met, but also what meeting it costs and where effort can be avoided.
- 2018–2026TÜV Rheinland, PPE laboratory Cologne, technical expert for PPE, technical lead from 2024 to 2026
- 2020 – 2026Member of a DIN standards committee
- 2023Certified Technical Business Administrator (IHK)
- 2018State-certified engineering technician, mechanical engineering
- 2014Apprenticeship as a precision machining mechanic
It rarely fails on the product.
In eight years of testing, hundreds of dossiers went through assessment. The great majority of delays did not originate in the product itself. And where they did, it was in details that could have been avoided at the start.
Working your own way into the Regulation costs weeks. That is exactly the time the consulting takes off your hands.
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Annex III
Incomplete technical documentation.
The Annex is more specific than most assume. Miss one point and the dossier comes back.
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Annex II
Avoidable design faults.
Small deviations in a seam, a material pairing or a fastener will fail a sample. Knowing the test criteria before the design stage means building them in rather than retrofitting them.
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Art. 12
Underestimated manufacturer role.
Anyone selling under their own brand becomes the manufacturer. With every obligation that entails.
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No hEN
No matching standard.
Without a harmonised standard there is no presumption of conformity. Innovative products fail here most often.
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Art. 14
Superseded standards.
When a standard is replaced or withdrawn, the presumption of conformity falls away. Often unnoticed.
Your notified body is not allowed to advise you.
Article 24 of the Regulation requires the independence of the conformity assessment body. It must not engage in activities that may conflict with its independence or integrity. The text of the Regulation names one case explicitly: "this applies in particular to consultancy services."
So the body deciding on your product may not show you how to build your documentation. You receive a list of findings, not a solution. That separation is right, and it is the reason a CE certification is worth anything at all. It does leave a gap, and that gap has to be filled by someone who knows both sides.
No commissions. No percentages either.
Anyone earning on a recommendation does not recommend the best body, but the most lucrative one.
Introduction commissions from test houses or manufacturing sites occur in this market, as do fees calculated as a percentage of certification costs. Both create an interest in a procedure becoming more elaborate than it needs to be.
Neither exists here. No introduction commission, no kickback, no share of testing fees. The fee comes solely from the client, is fixed before the project starts and is a clause in every contract.
That has a practical consequence. Where a procedure can turn out smaller than first assumed, because a test is not required or because another notified body delivers the same service for less, it goes into the roadmap. Even when that makes the engagement smaller.
- No introduction commissionNeither from notified bodies nor from test laboratories or manufacturing sites.
- No percentage feeThe fee does not depend on the cost of certification.
- Fixed price before the project startsA flat fee per service item, no open-ended timesheet.
- Contractually guaranteedA clause in every project contract, not just a statement on a website.
A conversation costs you 30 minutes.
Describe your product. After half an hour you will know which category it falls into, which procedure applies and where the pitfalls are. No obligation.