Faster track for approval of personal protective equipment
Testing of personal protective equipment for healthcare services during the corona pandemic (covid-19).
To enable faster access to personal protective equipment, for care services, healthcare and police, a fast-track process has been set up by the Swedish Work Environment Authority, on behalf of the Swedish Government. The fast-track process involves quicker product assessment, permitting manufacturers or importers to get their approved products to the healthcare services in a quicker way, without compromising with safety or quality.
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 the fast-track process works
The fast-track process for approval of protective equipment is made up by six steps, from contacting RISE to the point where your product is ready for use in care services, healthcare services or the police force.
- 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".
- RISE makes an evaluation which becomes the basis for the manufacturer's / importer's permit application to the Swedish Work Environment Authority.
- Send the evaluation documentation and a permit application to the Swedish Work Environment Authority for approval.
- After approval, the product can be used by care services, healthcare services or the police force, after risk assessment for each application area.
Frequently asked questions about the fast track for approval of protective equipment
How long does testing take via the fast track?
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.
Fast track with CE marking:
Testing and technical documentation evaluated. Evaluation results in a type-examination certificate. A CE-marked product does not need permission from the Swedish Work Environment Authority, but the manufacturer can label the product with the CE mark.
Will the product be CE marked?
Fast track without CE marking:
Products that are approved via the fast track without CE marking will not be CE marked, and may not be delivered after December 31, 2020. Please note that personal protective equipment that has been granted temporary permits under this method may not be sold on the other market. It is important that this is stated in the declaration of conformity.
Fast track with CE marking:
Products that are approved via the fast track with CE marking will be CE marked, but may not be delivered after December 31, 2020. This fast track can be supplemented with partial tests to achieve traditional CE marking, making the products valid for five years.
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 of personal protective equipment intended for use during the Covid-19 pandemic and subject to a simplified assessment process
This information describes what you, as a manufacturer, must do to get your product approved for use during the corona pandemic (Covid-19). The process largely corresponds to normal procedures employed in assessing conformity with Regulation (EU) 2016/425 for CE marking, but has been somewhat simplified.
The manufacturer shall compile and submit technical documentation as described below, together with samples. This applies to both Category II and Category III products. Normally, the production of Category III products is subject to monitoring, but, under the prevailing circumstances, this will not be carried out.
The technical file shall contain:
1. Risk analysis
The risk analysis can be divided into 2 parts.
Part 1: the product. Describe the risks the product will protect against. Using this as a guide, describe how the PPE was designed and how it works. What are the risks associated with use? For example, improper use, improper storage, materials, etc. How can these risks be reduced? For example, by means of labelling, instructions, e.g. if materials that cause allergic reactions or discomfort for the user are required, it must be ensured that these materials do not come into direct contact with the skin. Sharp edges, angles, etc. must also be avoided.
If harmonised standards are fully employed, they may be referred to in certain parts.
Part 2: production. Production must be carried out in such a way that all manufactured PPE has the same characteristics as the original design model(s) (i.e. the original design model tested). Taking into account how the PPE will work, assess which constituent components and which stages of production are critical in order for the PPE to function, and formulate a plan detailing how it will be ensured that production errors will be minimised. (For example: What checks need to be carried out during and after production? Which material specifications must be checked in particular upon delivery, which processes must be comprehensively controlled? Must production staff undergo special training?) These constitute in-house manufacturing inspections.
The risk analysis and a description of in-house manufacturing inspections must be included in the technical file.
2. Specifications and drawings
Detailed specifications shall be included in the technical file, in which all the constituent materials and components must be presented in detail. Also to be included are descriptions, drawings, photos or similar which describe the product in part or in whole so that the product can be identified through the documentation. A basic description of the production process (also refer to Risk Analysis above).
To consider in terms of material qualities and design:
It is important that the specifications are followed precisely during production. If modifications or alterations are necessary, they must be checked by the original type tester, and supplementary testing must be carried out if required. If you know beforehand that you will need to use alternative materials/components, ensure that all variants are tested.
3. User manual
A user manual shall be provided together with the personal protective equipment. The user manual and the personal protective equipment must be linked in order to clearly understand to which equipment the user manual belongs to (labelling, model and shipment/serial number, images). The user manual shall be provided in a language that is easy to understand for the user.
In addition to the name and address of the manufacturer, the user manual shall contain information about:
- The risks that the personal protective equipment is designed to protect against.
- Appropriate degree of protection, level of risk and corresponding user limitations.
- Description of how to apply, use and remove the personal protective equipment.
- It shall also be made clear if the personal protective equipment is for single use or if it can be reused.
- Storage, usage, cleaning, maintenance, service and disinfection of the personal protective equipment.
- How to control the personal protective equipment before use.
- Appendage that can be used together with the personal protective equipment and quality specifications of appropriate spare parts.
- Information on how the personal protective equipment cannot be sold on other markets (if it is not otherwise declared in the temporary permit)
The user manual and the personal protective equipment must be linked in order to clearly understand to which equipment the user manual belongs to.
4. Product sheet
The product sheet shall provide a general description of the PPE: What it protects against, what components it consists of, whether it is disposable or reusable, what materials it contains (general terms), contact details, etc. The product sheet can be combined with the user manual.
The user manual and product sheet must accompany the products when delivered to the user. The risk analysis and detailed specification do not need to be submitted.
The complete technical documentation is handled confidentially by RISE. The documentation that the Swedish Work Environment Authority require for permits is stated on their web page (a link is provided further down this page).
The product that is to be tested shall also be marked with the text “COVID-19”. If such a marking is not possible to perform, the smallest packaging shall be marked with the same text. If protective equipment manufactured in a third country cannot be marked with COVID-19 due to export obstacle reasons, the Swedish Work Environment Authority may accept another form of marking. Please contact them for discussing alternative marking.
*Protective equipment is split into three categories, depending on the level of risk they protect against.
Category I, is for products that protect against negligible risks that can cause, for example, bruising or abrasion.
Category III protect against risks that can be fatal or cause lasting injury.
Caegory II is all in between, and most products fall into this category.
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.