We understand you and can help!

As a manufacturer of PPE, you have a crucial responsibility for the safety and health of end users. Here are your most important tasks:

1) Design and produce your PPE in accordance with the essential health and safety requirements of Annex II of Directive 89/686/EEC.
2) Draw up the technical documentation in accordance with Annex III and carry out the conformity assessment procedure in accordance with Article 19 and affix the CE marking.
3) Provide your PPE with an identification number and state your name, trade name or brand as well as your contact address.
4) Either attach the EU declaration of conformity in accordance with 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 Annex II, point 1.4, which are comprehensible to end-users.
6) Keep the technical documentation for ten years after placing the product on the market.
7) Carry out random checks and inspections of non-compliant products and keep retailers informed of monitoring measures.
8) In the event of non-conformity, take immediate corrective action or carry out a recall if necessary.
9) Inform the competent national authorities in detail about the measures taken in the event of risks.
10) Provide all necessary information and documents at the request of the authorities and cooperate in risk minimisation measures.

As an importer of PPE, you have a crucial responsibility to ensure that only compliant products are placed on the market. Your tasks include:

1) Ensure 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 brand and address must be indicated on the PPE or packaging.
4) All instructions and information must be available in an easily understandable language for end users and authorities.
5) Carry out random checks and monitor storage and transport conditions.
6) Take immediate action if risks are identified and inform the relevant authorities.

The experts at easyCE are available to answer any questions you may have about compliance. Do you doubt the CE conformity of a machine you have purchased or is about to purchase? easyCE will be happy to check the CE documentation for you.

Als Händler von PSA sind Sie dafür verantwortlich, dass nur sichere und konforme Produkte auf den Markt kommen. Ihre Aufgaben umfassen:

1) Ensure that the PPE is CE-marked and that all necessary documentation and instructions are enclosed in the correct language.
2) Only place PPE on the market that fulfils the essential health and safety requirements. In the event of risks, inform the manufacturer or importer and the market surveillance authorities.
3) Ensure that the storage and transport conditions do not affect the conformity of the PPE.
4) Take necessary measures in the event of non-compliance and inform the responsible authorities about risks and measures.

The experts at easyCE will be happy to help you prepare or check the conformity assessment documents, which include product analysis, risk assessment, nameplate and the final declaration of conformity. We also check your operating instructions and their contents for conformity.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

Als Hersteller sind Sie in vielfältiger Art und Weise vom Thema CE betroffen.

  • Sie stellen CE-kennzeichnungspflichtige Produkte her.
  • Sie nutzen für die Produktion CE-kennzeichnungspflichtige Maschinen und Betriebsmittel.
  • Sie kaufen CE-kennzeichnungspflichtige Bauteile ein, die in Ihren Produkten aufgehen.

easyCE unterstützt Sie in allen drei Aktionsbereichen mit Ende-zuEnde Unterstützung. In Recherche von Richtlinien, Verordnungen und Normen. Ebenso wie der Erstellung der Produktanalyse, Risikobeurteilung, möglichen Messungen von Testlaboren, Kommunikation mit benannten Stellen etc.

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easyCE aids PPE categories for CE marking compliance.

Special features of conformity assessment and CE labelling for personal protective equipment (PPE)

Special features at a glance:

  • The PPE Regulation (EU) 2016/425 covers any device or means used to protect a person against damage to health
  • There are three categories of PPE: 1 PPE only protects against minor risks. All PPE that does not fall under Cat. 1 or categorie. 3 are category. 2 PPE. Categories. 3 PPE protects against risks that can lead to very serious consequences such as death or irreversible damage to health.
  • The requirements for the conformity assessment procedure depend on the category of PPE and go as far as mandatory type examination by a notified body for Cat. 3 PPE
REFERENCE PROJECTS

REFERENCE PROJECTS

CE marking of Cat. 1 mouth-nose cover

CE marking of Cat. 1 mouth-nose cover.

easyCE supports the entire conformity assessment procedure incl. instructions for use for an everyday mask as they are currently frequently used during the corona pandemic. Assessed as category 1 personal protective equipment.

CE marking and conformity assessment of a disinfection wristband.

easyCE supports the entire conformity assessment process, including the creation of a user supplement up to the declaration of conformity for a disinfection wristband ready for signature. Care has been taken to ensure that the disinfection wristband, as personal protective equipment, effectively protects the user from risks posed by bacteria, viruses, fungi and spores.

Considering: VO (EU) 2016/425, DIN EN 1500:2013

CE marking and conformity assessment of a disinfection wristband.
CE marking for FFP2 mask.

CE marking for FFP2 mask.

easyCE supports the entire conformity assessment procedure incl. instructions for use for an FFP2 mask in accordance with the Ordinance on Personal Protective Equipment. The mask is used to protect against the ingestion and spread of bacteria and viruses when speaking, sneezing, coughing and breathing in general. It should be noted in particular that PPE of a higher category, such as this FFP2 mask, requires testing by a notified body such as TÜV as part of the conformity assessment procedure. easyCE helped to organise and obtain all the necessary test reports.

Considering: 2016/425, EN 149:2001 + A1:2009

Frequently asked questions

FAQ

According to which directives must protective equipment such as corona masks bear a CE mark?

Personal protective equipment must bear the CE mark in accordance with the Regulation on Personal Protective Equipment EU 2016/425. The distinction between medical devices and personal protective equipment. We are happy to help you assess and decide whether your product should be classified 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 used to protect a person against damage to health. 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 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 examination by a notified body for Cat. 3 PPE

What categories of personal protective equipment are provided for 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.

As a manufacturer or importer of personal protective equipment, what do I have to take into account for conformity assessment and CE labelling?

easyCE will be happy to help you identify the directives and standards that apply to your product. We are also happy to help you with the next step of product analysis and risk assessment.

RELEVANT ARTICLES & EXPERTISE

RELEVANT ARTICLES & EXPERTISE

A NETWORK OF INDEPENDENT EXPERTS AT YOUR SIDE SINCE 1995

A NETWORK OF INDEPENDENT EXPERTS AT YOUR SIDE SINCE 1995

A NETWORK OF INDEPENDENT EXPERTS AT YOUR SIDE SINCE 1995

We are a comprehensive, specialised and established network of experts for all requirements arising from EC directives, laws, standards and regulations. We provide support with end-to-end expertise and proven methods from a wide range of projects and industries

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