All PPE products sold in Europe must comply with a specific set of rules, the Personal Protective Equipment Regulation, (EU) 2016/425. Expediting and managing the CE marking process for PPE is what we do.
The COVID-19 pandemic has created a tremendous demand for medical PPE. But many industries require non-medical PPE to protect their workers. If you manufacture these products and are considering entering the EU market, you’ll need to have a CE marking for your products. Our team of PPE compliance experts has the experience to help manufacturers and importers to get their products compliant.
If you need assistance obtaining a CE marking for your PPE products, enter your information, and we will reply within a day.
To get a CE marking for any PPE, it must conform to EU requirements. The first step is to determine which of the three categories apply to the specific product, where Category I is self certification and Category II and III are subject to certification by a Notified Body.
We assist manufacturers, distributors, and importers of PPE products by guiding them through the relevant Directives and standards process. If you need help and support obtaining the CE mark for your PPE, please contact the Zatisfy team today.
The CE marking process can be complex and time-consuming. The Zatisfy team has over 14 years of experience handling PPE documentation and testing. To save time and costs, hire us in the design phase of your manufacturing process. We will advise you on which directives your PPE product needs to comply with and then manage the certification process.
The European Directive PPE 2016/425/EU regulates Personal Protection Equipment (PPE). All PPE products must meet all the Directive’s requirements before being sold in the EU. Our experts can guide you through the CE marking process quickly and successfully.
Regardless of whether it protects against a safety or health risk, each PPE product must meet the requirements specified in the new Regulation (EU) 2016/425. The regulations also apply to systems that include PPE as part of the system or used with another product. The products must show compliance by affixing a CE mark before any manufacturer, importer, or distributor can sell in the EU.
Throughout the six stages of the CE marking process, we provide complete support. Manufacturers, importers, and distributors have various responsibilities when selling PPE in the EU. We guarantee that your product will have all necessary documentation and meet the Directive’s mandatory provisions. Once you send us the required equipment information, we will handle the process for you.