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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.

Do you accept that RISE will notify future customers within the same batch that they can contact you as you have already tested within the batch?
* Mandatory information By submitting the form, RISE will process your personal data.

General advice concerning protective equipment: skyddsutrustning@ri.se

This is how we process your request

  1. Contact RISE via the form above. 
  2. RISE will reply with a quote for the requested work and a preliminary date for when the work can start.
  3. 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".
  4. 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.
  5. 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.
  6. 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

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Information for manufacturers, importers and distributors of protective equipment to be CE marked

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Similarities and differences between fast track and CE marking

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Notified bodies

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Links to Läkemedelsverket

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RISE impartiality

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