MARKING FOR PPE.
DELIVERED BY CE EXPERTS.
Our experts deliver the assessment and documentation your personal protective equipment needs. We assess the protective function and risks, prepare the technical file and coordinate the required testing and notified-body work.
We prepare your EU declaration of conformity ready to sign once the required assessment is complete. Choose the full agreed process or individual tasks, with one dedicated expert coordinating the work and keeping your team informed.
Willy Lebherz
Founder and Managing Director of easyCE GmbH
DoC ready to sign!
We prepare your EU declaration of conformity once the applicable assessment is complete.
Risks and protection assessed!
We assess the intended protective function and the health and safety requirements for your PPE.
The right assessment route!
We identify the PPE category, relevant standards and notified-body procedures.
Technical documentation prepared!
We prepare the technical documentation, instructions and product information your PPE needs.
CE marking prepared!
We prepare the marking details, including notified-body identification where required.
Trusted by leading businesses. Chosen for results.
Your role determines your PPE responsibilities
PPE manufacturers
PPE importers
PPE distributors
Manufacturers must design and produce PPE in accordance with Regulation (EU) 2016/425. The intended protection determines the risk category and the conformity assessment route. Category II and III PPE require EU type-examination by a notified body; Category III also requires the applicable ongoing production-control procedure.
Prepare the technical documentation and EU declaration of conformity, affix the CE marking and provide the required product identification and instructions. Supply the declaration with the PPE or include the internet address where it can be accessed in the instructions. Keep the technical documentation and declaration for ten years after the PPE is placed on the market.
Maintain conformity in production and act promptly if the PPE is non-compliant or presents a risk. We assess your product, prepare the agreed documents and coordinate work with the notified body. Your team remains responsible for the manufacturer obligations.
Before placing PPE from outside the EU on the market, check that the manufacturer has completed the required conformity assessment, prepared the technical documentation and provided the correct marking, declaration and instructions.
Add the required importer identification, ensure that instructions are available in the language required by the destination country and protect conformity during storage and transport. Keep a copy of the EU declaration of conformity for ten years and ensure the technical documentation can be made available to authorities.
We review supplier documents, identify gaps and organise the agreed assessment and documentation work. Where PPE presents a risk or is non-compliant, corrective action and communication with the relevant economic operators and authorities may be required.
Before making PPE available, distributors must act with due care and check the CE marking, required documents, product identification and instructions. Do not supply PPE you believe is non-compliant until the issue has been resolved.
Storage and transport must not compromise conformity. Cooperate on corrective action and inform the relevant parties and authorities when the PPE presents a risk. Selling PPE under your own name or modifying it in a way that affects conformity can bring manufacturer responsibilities.
We review the product information and conformity documents so you know what is present, what is missing and which tasks need to be completed.
We check that the declared protective function, product identification and instructions are consistent across the records you receive.
Your CE project. Expertly handled.
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Approach to CE marking
Flexibility of support
Scope of support
Project contact
A clear, practical approach to CE marking
Our experts carry out the CE work, with a clear plan tailored to your product
Choose the full conformity assessment process or help with individual tasks
Your dedicated CE expert coordinates the agreed work throughout the project
Other CE service providers
Approach and project fit depend on the provider
Processes and flexibility depend on the provider
Scope agreed with the provider
Contact arrangements agreed for the project
CE software
A standardised workflow that your team adapts to the project
Your team manages the software and carries out the assessment
Features depend on the software and the modules purchased
Technical project support may require an additional service
We make CE marking simpler
Successful projects. Results that speak for themselves.
Product review for an everyday face covering
easyCE reviews the intended use, product classification and user information for an everyday face covering. The work focuses on making the product description and instructions consistent with the supporting evidence. Protective claims and the applicable assessment route must reflect the actual intended function.
Product compliance review for a disinfectant bracelet
easyCE reviews product compliance and prepares user information for a wrist-worn disinfectant product. The work considers the intended use, handling and the evidence behind the product claims. A wearable format alone does not establish that a product is PPE or demonstrate protection against microorganisms.
CE marking for FFP2 respiratory protection
easyCE carries out the agreed conformity work for an FFP2 particle-filtering half mask, including instructions and the technical documentation. The project considers EN 149:2001+A1:2009 and the PPE Regulation. We coordinate the required notified-body work and organise test reports for the Category III assessment route.
Product safety assessment for load-locking systems
easyCE assesses locking systems with an automatic pawl, focusing on load capacity, reliable engagement and mechanical hazards. The work reviews relevant lifting-component evidence under EN 13414-1 and EN 1677-1 alongside risk assessment under EN ISO 12100. The applicable product category follows the intended use of the system.
CE marking for hearing protection with audio functions
easyCE prepares the agreed conformity documentation for hearing protection with integrated audio functions. The work considers passive attenuation under EN 352-1 and the audio-output requirements of EN 352-8. The assessment addresses the protective function alongside the applicable requirements for the integrated electronics.
Your CE project in three steps
Step 1
Get free initial advice
Speak to a CE expert free of charge about the requirements for your product. Simply tell us what your product does and where you need support.
Step 2
Receive your proposal
We explain the assessment route and propose the work your project needs. Discuss the scope and ask questions before deciding how to proceed.
Step 3
We get it done
Your dedicated CE expert carries out the agreed work and keeps you informed throughout the project. We remain available for follow-up questions; ongoing monitoring and updates are agreed separately.
PPE conformity. Expertly delivered.
Frequently asked questions
Which rules apply to CE marking for protective masks and other PPE?
Personal protective equipment within scope must meet Regulation (EU) 2016/425. Respiratory protection such as FFP2 particle-filtering half masks follows the PPE requirements for its intended protective function.
A medical mask may instead, or also, fall under medical-device legislation depending on its intended purpose and claims. Classification is not a marketing choice. We assess the intended use and establish the applicable framework before planning the conformity work.
When is a product personal protective equipment?
PPE includes equipment designed and manufactured to be worn or held by a person to protect against one or more risks to health or safety. The Regulation also covers certain interchangeable components and connecting systems, subject to its definitions and exclusions.
The intended protection, design and product claims determine whether the product is PPE and which risk category applies. We review these together so the assessment addresses what the product is actually intended to do.
Which conformity assessment procedure applies to each PPE category?
Category I uses internal production control, Module A. Category II requires EU type-examination, Module B, followed by conformity to type based on internal production control, Module C.
Category III generally requires EU type-examination followed by either supervised product checks at random intervals, Module C2, or quality assurance of the production process, Module D. These procedures involve a notified body. We coordinate the agreed assessment work and prepare the technical documentation and EU declaration of conformity.
What are the three PPE risk categories?
Category I covers only the minimal risks listed in Annex I to Regulation (EU) 2016/425, such as superficial mechanical injury. Category II covers risks that are not listed in Category I or III.
Category III covers the listed risks that may cause death or irreversible damage to health, including harmful biological agents, falls from a height and harmful noise. The category follows the risks against which protection is intended, not the product's price or appearance.
How does easyCE help PPE manufacturers and importers?
We identify the applicable requirements, assess the product and its risks, prepare technical documentation and instructions, and coordinate the necessary testing and notified-body work. We also prepare the EU declaration of conformity for the responsible signatory.
Manufacturers remain responsible for conformity and production controls. Importers must check the required assessment, marking and documents before placing PPE on the market. We identify documentation gaps and carry out the agreed work to address them.
Expertise in PPE compliance
Willy Lebherz, Founder and Managing Director of easyCE
- Expert in product safety and compliance, since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Meister qualification in measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE specialises in product safety and conformity assessment. We combine engineering expertise with digital tools to help manufacturers, product users and distributors bring compliant products to market. We identify the applicable requirements, assess products, prepare technical documentation and coordinate tests.
Choose the full agreed assessment process or individual tasks, with a dedicated expert as your point of contact. Founded in southern Germany, we work with customers across Europe and worldwide.