CEMARKING for personal protective equipment MADE EASY!
WITH OUR EXPERT SUPPORT
All you have to do is affix the CE mark.
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
Receive your CE declaration of conformity ready for signature.
Risk assessment completed!
CE mandatory risk analysis conducted.
Relevant directives & standards applied!
Your product evaluated against relevant directives and standards.
Technical documentation created!
Receive a pragmatic, user-friendly operating manual.
CE mark attached!
Simply affix the CE mark and you're done.
Over 300 CE markings for construction products since 2021 and more every day...
This is what you need to take into account when CE marking your products
AS PRODUCER OF PPE
CE AS INTRODUCER OF PPE
CE AS DEALER OF PPE
As a PPE manufacturer, you have a crucial responsibility for the safety and health of end users. Here are your key tasks:
1) Design and manufacture your PPE in accordance with the essential health and safety requirements set out in Annex II to Directive 89/686/EEC.
2) Draw up the technical documentation in accordance with Annex III and carry out the conformity assessment procedure provided for in Article 19 and affix the CE marking.
3) Provide your PPE with an identification number and indicate your name, trade name or brand and contact address.
4) Either attach the EU declaration of conformity referred to in Article 15 or provide an internet address where it can be accessed.
5) Ensure that each PPE is accompanied by instructions and information in accordance with point 1.4 of Annex II which are understandable to end-users.
6) Keep the technical documentation for ten years after the product is placed on the market.
7) Conduct random checks and investigations on non-conforming products and keep distributors informed of surveillance activities.
8) In case of non-conformity, take prompt corrective action or recall action if necessary.
9) In case of risks, inform the competent national authorities in detail about the measures taken.
10) Provide all necessary information and documentation upon request from the authorities and cooperate in risk minimisation measures.
Only with easyCE, CE marking is worry-free
Approach to CE marking
Flexibility and concept of support
Scope & scale of support
Contact during project work
Simplified and pragmatic approach to CE marking to ensure compliance
In line with to your needs, our experts will take you along the CE marking journey
You choose our support model: From "One-stop-shop full service", to partial and modular - whatever you prefer
First things you receive your dedicated, personal CE expert who will support you along the entire process
Other CE service providers
Often without a sense of proportion and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in the extent of support
Mostly personal contact
CE software
Follows a standardised process that does not take special features into account
Double burden for you: Software administration + no support for processing
Only according to software scope and purchased modules
No contact
We simplify CE-marking not the opposite
Reference projects
CE marking and declaration of conformity for Cat. 1 mouth-nose coverings
easyCE supports the entire conformity assessment procedure, including instructions for use for everyday masks, which are currently in frequent use during the coronavirus pandemic. Assessed as Category 1 personal protective equipment.
CE marking and declaration of conformity for a disinfectant wristband
easyCE supports the entire conformity assessment process, including the creation of a user information sheet and a ready-to-sign declaration of conformity for a disinfectant wristband. Care has been taken to ensure that the disinfectant wristband, as personal protective equipment, effectively protects the user against risks posed by bacteria, viruses, fungi and spores.
Considering: VO (EU) 2016/425, DIN EN 1500:2013
CE marking and declaration of conformity for FFP2 masks
easyCE supports the entire conformity assessment procedure, including instructions for use for an FFP2 mask in accordance with the Personal Protective Equipment Regulation. The mask protects against the absorption and spread of bacteria and viruses when speaking, sneezing, coughing and generally when breathing. It is particularly important to note that higher category PPE, such as this FFP2 mask, requires testing by a notified body such as TÜV as part of the conformity assessment procedure. easyCE assisted in the organisation and procurement of all necessary test reports.
Considering: 2016/425, EN 149:2001 + A1:2009
Conformity assessment procedure and CE marking for load clip locking systems
easyCE successfully supports CE marking up to the ready-to-sign Declaration of Conformity for innovative locking systems with automatic pawl. The particular challenge was providing evidence of load capacity according to EN 13414-1 and the safety requirements per EN 1677-1 for rigging components. Through precise load testing, a safe working load range could be defined that meets personal protection requirements according to EN ISO 12100 and ensures reliable locking mechanisms with high load-bearing capacity.
Considering: 2016/425, 2006/42/EU
Conformity assessment procedure and CE marking for hearing protection with communication function
easyCE successfully supports CE marking up to the ready-to-sign declaration of conformity for modern hearing protection with integrated communication function. The particular challenge was compliance with EN 352-8 requirements regarding the limitation of the audio signal to 82 dB(A) while ensuring the protective function according to EN 352-1 for passive noise attenuation.
Considering: 2016/425, 2014/53/EU
Learn more about our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
We support you with CE marking and all accompanying measures
Frequently asked questions
According to which guidelines must protective equipment such as corona masks bear a CE marking?
Personal protective equipment must bear the CE marking in accordance with the Personal Protective Equipment Regulation EU 2016/425.
However, the distinction between medical devices and personal protective equipment is often difficult. We are happy to help you assess and decide whether it is better to classify your product as PPE or a medical device.
How is personal protective equipment defined and when is a product "personal protective equipment"?
The PPE Regulation (EU) 2016/425 covers any device or means intended to protect a person against damage to their health.
There are three categories of PPE: Cat. 1 PPE protects against minor risks only. All PPE that does not fall under Cat. 1 or Cat. 3 is Cat. 2 PPE. Cat. 3 PPE protects against risks that can lead to very serious consequences such as death or irreversible damage to health.
What process and requirements apply to the conformity assessment of personal protective equipment?
The requirements for the conformity assessment procedure depend on the category of PPE and go as far as mandatory type testing by a notified body for Cat. 3 PPE
Which categories of personal protective equipment are covered by Directive EU 2016/425?
There are three categories of PPE:
- Cat. 1 PPE only protects against minor risks.
- All PPE that does not fall under Cat. 1 or Cat. 3 is Cat. 2 PPE.
- Cat. 3 PPE protects against risks that can lead to very serious consequences such as death or irreversible damage to health.
What do I have to consider as a manufacturer or importer of personal protective equipment when assessing conformity and CE marking?
easyCE will be happy to help you identify the guidelines and standards that apply to your product. We will also be happy to help you with the next step of product analysis and risk assessment.
Trust the experts of product safety and 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
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know the special features that you need to take into account when CE marking your product and we are happy to help you.