EU Market Access Requirements for PPE/DPI
Do you have personal protective equipment ready for deployment in the European market? Every company or entity is required to obtain CE-Mark before trading personal protective equipment in the European market. Obtaining the CE-Mark means that you, as the responsible entity, comply with the legal requirements of the European market, especially the European Directive 89/686/EEA. Furthermore, your product must also conform to the requirements of Regulation (EU) 2016/425. These regulations are in place to ensure that the personal protective equipment is safe to use.
Which PPE Products are required to comply with the regulations:
The requirements of the directive apply to every personal protective equipment that a user may wear or hold for protective purposes. It is of no concern whether the product protects against safety or health risks or whether it provides protection against multiple risk types. The regulations are also applicable to systems that consist of a PPE and another external product. Hence, it is clear that all types of PPE products require compliance with the regulations.
Access the EU Market: Our Assistance:
Your personal protective equipment and its documentation need to comply with the EU Directives. Every case is unique and requires an approach according to its attributes. We guarantee your personal protective equipment to meet all mandatory requirements by offering a certification process that is quick and customized according to your needs. We will handle everything after you provide specific information about your product and guarantee that your personal protective equipment complies with the requirements.
We can also support in testing or gap analysis over already performed tests. Reach out
How do we work?
We review your current documentation and testing to assess the level of compliance. We guide and help to prepare any missing documentation or cover any gaps. We liaison with selected test labs and notified bodies to help you get your products smoothly into the market. We offer Auth. Rep. support so you have a single contact point to deal with your CE compliance matters.
CE Mark Services
- Product Documentation Review
- Compliance Gap Assesments
- Liason with Notified Bodies
- Appointing of EU Auth. Rep.
- Creation support of Technical File
- Selection of Lab and performance of testing
- EC Declaration Of Conformity
Price and Time
Price and time depend of the type of product and the current status of your documentation. We have a direct connection with notified bodies and accredited test labs in Europe and also in Asia. This helps us to streamline the process and speed up the CE marking authorization. Fill in the quick form to get a quote straight away!