TÜV NORD GROUP has acquired the Swedish Notified Body for Medical Devices RISE MNB. The acquisition strengthens TÜV NORD's position in the Nordic market and expands its service portfolio there to include the assessment of medical devices in various product groups.
Hanover/Stockholm: TÜV NORD GROUP has acquired the Swedish Notified Body for Medical Devices RISE MNB. The acquisition strengthens TÜV NORD's position in the Nordic market and expands its service portfolio there to include the assessment of medical devices in various product groups. RISE MNB is a Notified Body for medical devices according to MDR 2017/745 and is accredited according to ISO 13485 for certification by SWEDAC.
RISE MNB is a wholly-owned subsidiary of the state-owned RISE AB and was founded in 2022 to strengthen the competitiveness of the Swedish medical device industry and give its customers access to the entire EU market. Today, RISE MNB is an established Notified Body for conformity testing in the medical sector according to MDR 2017/745 and is endeavouring to be allowed to carry out conformity testing according to IVDR 2017/745 (in vitro diagnostics) soon.
With the acquisition, RISE MNB will be renamed TÜV NORD Scandinavia MNB and will serve as the central point of contact for system certification in Scandinavia. "This acquisition is a significant step for TÜV NORD to strengthen our presence in the Nordic countries and expand our service offering," says Ralf Thomsen, Senior Vice President Medicle Device International at TÜV NORD. "We look forward to further expanding our expertise in the field of medical certification. With three Notified Bodies in the future, we are a strong partner to the medical device industry - worldwide," says Thomsen. TÜV NORD GROUP has been active in Sweden for 25 years, primarily in the nuclear industry, in service inspection and conformity assessment of pressure equipment.
TÜV NORD Scandinavia MNB is managed by Åsa Betten, who successfully built up the Notified Body at RISE with her team. Björn Wendtsson, General Manager TÜV NORD Scandinavia, and Ralf Thomsen will support Åsa Betten on the Board. "We will continue to develop the offering for companies in the medtech sector under the TÜV NORD flag and provide secure access to certification for small and medium-sized companies in Sweden in accordance with MDR and IVDR. All ongoing certifications will continue as planned. We ensure continuity and stability in our processes and work," says Åsa Betten. "With this acquisition, we are sending a clear signal of our commitment to the Nordic region and our willingness to invest in innovative solutions that meet the needs of our customers," adds Björn Wendtsson.
TÜV NORD Scandinavia MNB will be the only registered Notified Body for IVDR in Sweden and currently offers services for MDR, ENISO13485 and soon also IVDR. RISE MNB brings a team of 20 employees to the company. TÜV NORD Scandinavia MNB will be TÜV NORD's third MDR designated body. TÜV NORD Medical Device International employs a total of 150 people worldwide.
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