Medikro obtains EU-MDR certification, reinforcing commitment to quality and patient safety
Kuopio, Finland
Medikro has received certification under the EU Medical Device Regulation (MDR 2017/745) for its devices and quality management system. The certification was granted following a comprehensive audit and technical documentation review.
The EU-MDR is one of the most robust regulatory frameworks for medical devices in the world. It was introduced by the European Commission to improve the safety, performance and transparency of medical technologies across the EU. This new certification supersedes Medikro’s earlier conformity under the Medical Devices Directive (MDD).
“This milestone reflects the high level of care, design and compliance we maintain throughout our development and manufacturing processes,” said Jani Timonen, Head of product at Medikro. “MDR certification is more than a regulatory achievement – it’s a commitment to clinicians and patients who rely on the accuracy and safety of our solutions.”
With MDR certification in place, Medikro strengthens its foundation for long-term growth across Europe and other regulated markets, ensuring business continuity and full regulatory alignment.
About Medikro
Medikro designs and manufactures spirometry systems used by healthcare professionals all over the world. Established in Finland over 45 years ago, the company offers user-friendly, accurate and connected respiratory care solutions for primary care, occupational health and hospital settings.
