Skip to main content
RISE logo

In crisis new products are born - but don't forget to certify

Many companies want to help and produce products and create services that will reduce the spread of infection, support healthcare, help people in quarantine and make society cope with prevailing circumstances. Companies are starting to manufacture hand sanitizer and mouthguards or launch digital services to facilitate distance learning, for example. When crises arise, like the corona pandemic, the opportunity to think new and different is created. And you want to quickly launch your new idea. But don't forget to certify the new product. RISE assists SMEs with certification.

– Right now we see many companies that want protective equipment for healthcare approved. There is great shortage of several different types of protective equipment, so getting new safe products to the market quickly is of course extremely important. RISE has a dialogue with national authorities to facilitate the process of getting equipment available for healthcare without compromising safety and performance, says Dag Sjöholm, research and business developer for certification at RISE.

Multiple levels of certification

Certification is based on multiple levels. Sjöholm divides them into three different categories in terms of requirements: international, national and industry, with international requirements being superordinate:

“Basically, the international requirement supersedes the national, and the national supersedes industry requirements.” 

The most common international certification is the CE marking. 

“It’s a European certification mark required to sell products in Europe. It’s very good that a common regulatory framework exists for the whole of Europe, instead of every country having its own specific regulations, but you can’t take a CE-marked product and start selling it in the US, since there are different regulations there,” says Sjöholm. 

Do you wish to be contacted?

The SME support department at RISE offers advice and expertise all over the country. Fill out the form below and we will be in touch!

17 + 1 =

* Mandatory information By submitting the form, RISE will process your personal data.

Government determines local requirements

When it comes to national requirements, it is often government agencies, such as the Swedish National Board of Housing, Building and Planning and the Swedish Energy Agency, that determine which requirements a product should fulfil. 

“It may have to do with a product satisfying specific noise requirements or sealing requirements,” says Sjöholm. 

The third level, in which industry sets the standard, can involve a trade association seeking to clarify and ensure that the products being sold meet specific requirements. 

“So that, for instance, you don’t sell doors that lack certain fire safety properties or whatever it may be,” says Sjöholm. 

Don't wait too long

In exceptional situations like what we have currently with the corona pandemic, development of new products may go faster than usual. That makes it even more important that you do not wait too long to begin the certification process.

“Sometime during prototype testing is a good time, I would say. If you’ve already begun production, it’s a bit too late if there are indications that something is wrong.” 

If, prior to the process commencing, a company requests assistance and advice from another company that issues certification, it means that that company is precluded from issuing the certification. 

“They are then no longer deemed impartial, so it’s something important to consider,” explains Sjöholm. 

Once the certification process is underway, the actual product is thoroughly tested at the same time as production is inspected in order to ensure that all products maintain the same quality. 

“You examine the process that the products undergo and, sometimes, a few samples are tested to ensure that the customer is not just sending products that look good,” says Sjöholm. 

Valid for five years

When all steps are completed and approved, a certificate is issued and the company can label their product with a certification mark. A certificate usually applies for five years. If something about the product were to change, such as new materials used in manufacturing or if the product is to be sold in a new segment, new certification is required. 

For those needing advice on and support with certification, help can be sought from, for example, trade associations and Almi. 

“It’s possible to apply for funding while also receiving help regarding what to consider and where to go for certification,” says Sjöholm.

Contact person

Dag Sjöholm

Forsknings-och affärsutvecklare

+46 10 516 57 36

Read more about Dag



Support for small and medium-sized enterprises in times of corona pandemic

Crises can pose challenges when markets disappear. But they might as well bring opportunities; new markets are opening up, time is freed up for competence and product development, support for business restructuring so that it stan…

Succeed in growing your company

For the vast majority, starting a company and getting operations up and running usually goes smoothly. But the challenges are never as great as when it’s time for your company to grow. Company expert Kajsa Hedberg, CEO at SISP, of…


When you buy a cycle helmet, you want to know that it will provide protection if you fall from your bicycle. You want to know that an independent party has tested and approved the product. Certification is a guarantee of quality t…

Product Certification

Product certification is a guarantee of quality that creates confidence in the market. This may apply to a product’s durability, as well as other qualitative aspects such as data security and environmental sustainability.

Testing of protective devices

Testing of products and devices according to EN 149, EN-ISO 20743, EN 14683, EN 1500,EN 1499, EN 166 and EN ISO 18526-3.


Whether you have imported toys from China, purchased fuel without knowing its tar amount or quality-assure a proprietary product, RISE is here to help. We avail ourselves of several thousand different testing methods to fulfil our…

Medical devices

As Sweden’s population ages, our need for care increases. When medical technology products help patients to recover faster and they spend shorter time in hospital, the suffering of patients is reduced, and the healthcare system sa…

Biocompatibility evaluation

All medical devices have to undergo a biological evaluation of biocompatibility to fulfill the requirements in the EU Medical Device Regulation (MDR). We can help you with everything from setting up a biological safety evaluation …