The Swedish Life Science Industry Guide in RISE Medical Notified Body

RISE Medical Notified Body (RISE MNB) is a Swedish notified body supporting medical device companies in gaining access to the European market. RISE MNB provides independent, quality-assured certification in accordance with EU medical device regulations. 

RISE MNB performs assessments and certifications under the EU Medical Device Regulation (MDR 2017/745)* as well as quality management system certification in accordance with ISO 13485**. Its services cover the entire certification lifecycle, from application and initial assessment to ongoing surveillance and recertification. 

RISE MNB works with a broad range of medical devices, including software, dental devices, sterile products, and assistive devices, across multiple risk classes, and handles applications, documentation and communication in Swedish and English. Through a combination of technical competence, regulatory expertise, and close collaboration with its clients, RISE MNB aims to be a long-term and accessible partner in a complex regulatory landscape. 

RISE MNB are expected to be designated for In Vitro Diagnostic Medical Device Regulation (IVDR) during 2026. Application process is ongoing.

*RISE MNB with identification number 3033 is designated by the Swedish Medical Products Agency in accordance with Regulation (EU) 2017/745 (MDR).

**RISE MNB with accreditation number 10597 is accredited by Swedac for the certification of management systems in accordance with ISO/IEC 17021-1.

Company vision
"We are driven by a strong commitment to patient safety and customer focus. Our mission is to enhance patient safety by ensuring regulatory compliance for our medical technology customers. Through close customer collaboration, high accessibility, and clear communication, we support the development and innovation of medical devices by delivering an efficient and transparent certification process."