Testing and type inspection certificate prior to CE marking of protective equipment
For those who manufacture, import, distribute and use protective equipment during the covid-19 pandemic.
RISE is developing our offer as a Notified Body for CE marking according to the customer inquiries that are now coming to us. There, manufacturers, importers and distributors want help from us with testing and type control that results in type control certificates with a normal validity period of 5 years according to Regulation (EU) 2016/425 (Regulation on personal protective equipment).
RISE will continue to perform testing that can be used as a basis for the Swedish Work Environment Authority's temporary permit (now at the latest until 2021-12-31). Such testing will e.g. to be required when users themselves want to try personal protective equipment that is not CE marked.
Request a quote for testing of protective equipment
Use the form below to get a quote for testing of protective equipment.
General advice concerning protective equipment: firstname.lastname@example.org
This is how we process your request
- Contact RISE via the form above.
- RISE will reply with a quote for the requested work and a preliminary date for when the work can start.
- Send your product and product information to RISE for a quality control. To speed up the handling of your case, ensure that the requirements for the product information are met. The requirements can be found below under the heading "Information for manufacturers of personal protective equipment".
- If we identify deficiencies in the test or type check, you will be contacted by RISE when that property of the test or sub-part of the type check is completely completed.
- For type inspection prior to CE marking: RISE creates a test report, examines documentation and if everything looks good, a type inspection certificate is issued. With this documentation, manufacturers, importers and distributors can then CE mark their product.
When applying for a permit to the Swedish Work Environment Authority: RISE creates a test report which becomes the basis for the manufacturer's, importer, distributor or user's permit application to the Swedish Work Environment Authority. Send documentation and permit application to the Swedish Work Environment Authority for approval.
- When CE marked or given the permission from the Swedish Work Environment Authority, the product can be used by approved users (CE-marked no restrictions, permits from the Swedish Work Environment Authority only in health, care, the armed forces, the police, rescue services, ambulance personnel and others working to prevent the virus from spreading) . Professional use must be preceded by a risk assessment for the area of use.
Frequently asked questions about the approval of protective equipment
What are the advantages of CE marking instead of fast tracks and permits from the Swedish Work Environment Authority?
Products that have undergone normal type inspection and are CE-marked can, unlike products that have had a type inspection certificate with a short validity period or temporary permits from the Swedish Work Environment Authority:
– be sold for a longer period to be determined by the manufacturer
– sold throughout the EU
– used in all activities (not only care, nursing, the armed forces, the police, the rescue service, ambulance personnel and others who work to prevent the virus from spreading)
– the type-examination certificate has a normal validity period of 5 years, unlike products via high-speed tracks which have a much shorter approval period
If I have a CE marking via the fast track, can I have it extended to CE marking and type inspection certificate for 5 years?
Previous tests and completed type checks can continue to be used as part of the basis for type check certificates. Where there has been simplified testing in the "fast track" or inspection before type inspection certificates, additions need to be made.
How long does testing and review for type inspection certificates take??
The processing time depends partly on the type of product to be tested, partly on any queue time in RISE testing operations and partly on the quality of the product documentation that is submitted together with the product. Under normal conditions and when complete product information is sent, the testing itself takes between one and three weeks to complete.
How much does the test cost?
The price of the test depends on the type of product to be tested. RISE will return with a quote on the work to be performed based on your request.
Will RISE approve my product?
Fast track without CE marking:
The fast track is no guarantee that the product will be approved. RISE assesses whether the personal protective equipment meets the basic health and safety requirements, and delivers an assessment report which must then be submitted to the Swedish Work Environment Authority.
Testing and technical documentation are evaluated. Evaluation results in a type control certificate. A CE-marked product does not need a permit from the Swedish Work Environment Authority, but the manufacturer can label the product with the CE mark.
What are batches?
Even if a product has been tested once with an approved or failed result, the result only applies to the current batch - another batch from the same manufacturer may have completely different results. This is because the manufacturer may, for example, have received material from completely different suppliers between batches, and different materials may have completely different properties. Test results refer to a batch, nothing more.
Information for manufacturers, importers and distributors of protective equipment to be CE marked
This information describes what you as a manufacturer must do to get your product CE marked. You will receive information about what a Notified Body such as RISE does in the categories for protective equipment, if your product needs external testing, sampling, inspected in a production environment and technical documentation.
Similarities and differences between fast track and CE marking
Here we describe the similarities and differences between fast tracking with/without CE marking and traditional CE marking. Personal protective equipment (PPE) comes in numerous forms, and we deal with PPE that is classed in various ways based on established health and safety requirements. In the table below, Class II and Class III products are described collectively (anything that protects against risks more serious than trivial risks such as those that may result in e.g. abrasions, bruises, chafing). Importers and manufacturers constitute potential clients.
Notified Bodies are independent organizations that assist and monitor manufacturers' work to verify that products comply with EU regulations. This is done through testing, verification and certification in accordance with EU legislation.
The name notified body comes from the Member State reporting the organizations approved to the European Commission, which in turn assigns each notified control body a four-digit identity number and publishes the name and address in the Commission's journal, Official Journal (OJ). A list of the notified bodies working in various fields can be found in the European Commission's public database Nando.
Swedac is the national reporting authority in Sweden. This means that Swedac assesses and appoints bodies after consulting the relevant authorities, and then notifies the bodies to the European Commission. Swedac also exercises supervision of notified bodies, in collaboration with the sector responsible authority.
RISE is one of the appointed bodies in Sweden. When it comes to personal protective equipment, only RISE is approved as a notified body. In addition to RISE, medical equipment is also available for Intertek.
Links to the Swedish Work Environment Authority
RISE creates trust in its services by being objective in the handling of assignments. This means being aware that assignments are performed in an impartial manner without personal gain and that sufficient evidence is sought to show that the service or product meets the requirements.
This also means that RISE cannot participate in the development, production, maintenance, distribution, installation or can perform consulting services for products that we certify.