What is CE Marking?
A definitive guide to CE marking in Europe. Discover what a CE marking is, what products require a CE mark, and why a CE mark is required on the EU market.
Specialised clothing such as goggles, gloves, helmets or masks that are intended to protect the wearer from inherent hazards have a broad spectrum of applications from heavy machinery environments to sports.
These hazards may include biohazards, heat, physical, electrical, heat, chemicals or airborne.
Until the publication of the Personal Protective Equipment Regulation 2016/425/EU on March 9, 2016 the subsequent two year transition period, the Personal Protective Directive 89/686/EEC was the reigning legal framework for medical devices. While the Personal Protective Regulation 2016/425 repealed the PPE Directive 89/686/EEC with effect from 21 April 2018, equipment that has a valid EC-type examination Certificate issued according to the old Directive may still be placed on the market until the expiration date of corresponding EC-type examination certificate (no later than 21 April 2023). From April 21st, 2018, the PPE Regulation 2016/ 425/EU became fully applicable in the EU as the main legal framework for personal protective equipment.
Any product placed and made available on the EU market (either through e-commerce or traditional retail) must comply with the Personal Protective Equipment Regulation 2016/425.
Non-EU based manufacturers should appoint European Authorized Representative (EAR). (A manufacturer is defined as any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his name or trademark.)
Higher-risk PPE (Category II & III) will require the intervention of a Notified Body to obtain the CE Mark.
Products which fail to comply may be subject to public notification (RAPEX), withdrawal requirements, warehousing fees, fines or total destruction of the products.
The new Regulation (EU) 2016/ 425 (PPE Regulation) of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating personal protective equipment is fully entered into force on the 21st of April 2018 replacing the Personal Protective Directive 89/686/EEC. The PPE Regulation comes into full effect from 21st April 2019.
The PPE Regulation ensures that all personal protective equipment provides a high level of protection of the health and safety of users.
Therefore, the PPE Regulation lays down common standards to provide adequate protection against the risks which is intended to protect.
Per the Personal Protective Equipment (PPE) Regulation (EU) 2016/425, PPE is defined as:
The PPE Regulation applies to all sorts of PPE being placed on the EU market except for those:
There are defined three categories of equipment based on the risk against which the equipment is intended to protect users.
Category I – Minimal risk
In this category, the PPE is designed to protect people from minimal risks:
Category II – Intermediate Risk
This category covers risks other than those defined by neither Category I nor Category III.
Category III – Serious Risk
The PPE designed to protect people from risks that may cause very serious consequences such as death or irreversible damage to health:
Each risk category of PPE must comply with clearly defined conformity assessment modules prior to being placed on the market. PPE covered by categories II and III requires the product to be certified by a Notified Body (NB). The Notified Body will issue an EU type-examination certificate following successful evaluation of a manufacturer’s technical file and independent testing report.
PPE shall meet certain health and safety requirements (Annex II) to not endanger person and properties as those:
PPE which is in conformity with harmonized standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex II covered by those standards or parts thereof.
The manufacturer compiles the technical documentation, which makes it possible to assess whether the PPE equipment complies with the requirements of the Regulation. It contains at least the elements set out in the Annex III.
Non-compliant products enter the EU Market everyday – whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.
Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market. In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:
The professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.
It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves. Post-marketing surveillance activities include, but are not limited to:
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.