Sweden has a new notified body for medical devices - RISE MNB
21 March 2024, 08:03
On 7 March 2024, RISE Medical Notified Body AB (RISE MNB) was designated as a notified body for MDR 2017/745 .
The Swedish Medical Products Agency has designated RISE MNB as a notified body for medical devices under the MDR. The scope of our designation can be found in the European Commission’s database of notified bodies NANDO.
We can now accept applications for MDR certification. For manufacturers who are certified according to the old MDD regulations and want to apply the rules for transitional provisions under MDR Article 120, a formal application must be submitted by 26 May 2024.
We accept applications, documentation and correspondence in either Swedish or English.
Medical devices made available on the European market must comply with the requirements of MDR 2017/745 and must then be CE marked by the manufacturer. For medical devices with a risk class higher than I, manufacturers must engage an impartial third-party, known as a notified body, to carry out a conformity assessment under MDR 2017/745.
Our mission is to create patient safety by having our skilled employees ensure regulatory compliance for our medical device customers.
RISE MNB operates independently, impartially and objectively in relation to manufacturers and other economic operators involved in conformity assessment, and applies confidentiality and secrecy requirements.
RISE Medical Notified Body AB is a subsidiary of RISE Research Institutes of Sweden AB.
Contact us for more information.