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IVDR – the recognition of patient safety


IVDR | November 2, 2022

Safety: what comes to mind when you hear that word? Keeping your loved ones safe? You probably ask your children to wear a helmet when riding a bike or going horseback riding. The knowledge that everyone within that airport has gone through the security check. Is it a brand like Volvo that you think of? Or do you connect safety with something else? Symbols of safety are many. What certificates or trademarks do you trust when buying a product or service? The world is full of different quality assurances. When you google safety certifications, you will get over 13 billion answers.

To us, being a provider of medical devices that affect patients’ life, we take safety very seriously. For us, patient safety is in our DNA. Already in 2004, our founders pioneered the genetic testing market and built a company with empathy as one of its core values. Empathy for the patient is part of every step of our product development processes.

Our solutions save lives. In Europe, the new IVD regulation has entered into force. Solutions like ours, defined as medical devices for in vitro diagnostics, must be CE-IVD marked before they are released on the European market. The CE-IVD stamp is then the highest marker for patient safety. This has, up to recently, been done by complying with the IVD directive. A directive is a set of rules for all EU member states but the EU leaves it up to each state to transfer the rules to a national directive. A regulation, however, is directly a law in each member state and leaves no room for local interpretation. To be CE-IVD marked in the future all products sold must comply with the more comprehensive regulation.

As you care about health and safety, you, of course, would buy products that are CE-IVD marked and certified according to the new regulation. Why would you settle for less? If you would buy yourself a new car and safety was important to you, how would you evaluate the security level of a car? Perhaps you would consult the Euro NCAP rating, the European new car assessment program. A credible institution that helps consumers identify the safest choice for their needs. The IVDR has the equivalent importance for patient safety for medical products.

So, when the IVDR was announced back in 2017, we embraced it with wide arms. No more directives where each European country interprets the directive according to their own law. Now we have a common framework that applies to all for the ultimate safety of the patient. Why wait to transfer to a certification that is a benefit to public health? For us, the transition is empathy for patients and for our customers that trust us by buying our products. We care about our products, our customers, and you. Next time you come across a diagnostic test check if it is from an IVDR certificate company.

By Matilda Jernevad



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