for personal protective equipment done
with our help!
We take care of your entire CE marking process, including accompanying measures.
All you have to do is affix the CE mark.
Willy Lebherz
Managing Director of easyCE GmbH
Declaration of conformity done!
You will receive a declaration of conformity ready for signature!
Risk assessment completed!
We test your machine against relevant directives and standards
Applicable standards & guidelines applied!
We test your machine against relevant directives and standards
Technical documentation created!
You receive a pragmatic, user-friendly operating manual
CE mark attached!
All you have to do is to affix the CE mark
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This is what you need to take into account when CE marking your products
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.
As an importer of PPE, you have a key responsibility to ensure that only compliant products are placed on the market. Your tasks include:
1) Make sure that the PPE complies with the requirements of the Regulation and that the CE marking is correctly affixed.
2) Ensure that the necessary technical documentation and the EU declaration of conformity are available to the national authorities.
3) Your name, trade name or trademark and your address must be indicated on the PPE or its packaging.
4) All instructions and information must be available in a language easily understood by end-users and authorities.
5) Carry out random checks and monitor storage and transport conditions.
6) If risks are identified, take immediate action and inform the competent authorities.
The experts at easyCE are available to answer any questions you may have about conformity. Do you have any doubts about the CE conformity of a machine you have purchased or are about to purchase? easyCE will be happy to check the CE documentation for you.
As a PPE distributor, you are responsible for ensuring that only safe and compliant products are placed on the market. Your tasks include:
1) Make sure that the PPE is CE marked and accompanied by all required documentation and instructions in the correct language.
2) Place only PPE on the market that complies with the essential health and safety requirements. In case of risks, inform the manufacturer or importer and the market surveillance authorities.
3) Ensure that storage and transport conditions do not compromise the conformity of the PPE.
4) Take necessary measures in case of non-conformity and inform the competent authorities about risks and measures.
The experts at easyCE will be happy to help you prepare or review the conformity assessment documents, which include product analysis, risk assessment, type plate and the final declaration of conformity. We will also check your operating instructions and their contents for conformity.
With easyCE is CE mark very "easy"
Approach to CE mark
Diversity and concept of support
Extent of support
Contact during project work
Simplified CE labelling
Maximum flexibility and no red tape
All-round carefree, or modular - as required
Personal CE expert for you, customised to your needs
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 are convinced that you are looking for
support that takes work off your hands
and does not
cause even more work
Reference projects
CE marking of Cat. 1 mouth-nose covering
easyCE supports the entire conformity assessment procedure including instructions for use for an everyday mask such as those currently in frequent use during the Corona pandemic. Rated as personal protective equipment of category 1.
CE marking and conformity assessment of a disinfection bracelet
easyCE supports the entire conformity assessment procedure, including the creation of a user supplementary sheet and the declaration of conformity for a disinfection bracelet that is ready for signature. Care was taken to ensure that the disinfection bracelet, as personal protective equipment, effectively protects the user against risks posed by bacteria, viruses, fungi and spores.
Considered: Regulation (EU) 2016/425, DIN EN 1500:2013
CE marking for FFP2 mask
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 serves to protect against the absorption and spread of bacteria and viruses when speaking, sneezing, coughing and generally when breathing. It is particularly important to note that PPE of a higher category, such as this FFP2 mask, require testing by a notified body such as TÜV as part of the conformity assessment procedure. easyCE helped with the organization and procurement of all necessary test reports.
Considered: 2016/425, EN 149:2001 + A1:2009
More about reference projects and history
CE labelling 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
Get an offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We would be happy to explain the necessary steps over the phone.
Step 3
Arrange implementation
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.
We are experts in product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity 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.