FAQ - RISE MNB
Find the answers to the most frequently asked questions.
Which companies or organisations need a notified body?
Answer: Manufacturers who want to place a medical device on the market and sell it on the European market must first CE mark their product.
Different rules and procedures apply to different risk classes of products.
For products with the lowest risk class (Class I according to MDR), manufacturers must complete the CE marking process on their own. However, there are some Class I devices under the MDR that require the involvement of a notified body. These Class I products are:
- Class 1s: Products delivered in a sterile condition.
- Class Im: Products that have a measuring function.
- Class Ir: Products that are reusable surgical instruments.
The scope of the product review increases with increasing risk class, with Class III being the highest risk class followed by Class IIb and Class IIa. Products falling within these risk classes must always be subject to a notified body for conformity assessment.
Which MDR codes have you been designated for?
Answer: A notified body is designated for a specific scope, meaning specific device risk classes and specific MDR codes.
As a manufacturer, you must ensure that you use a notified body that is designated for the specific products you manufacture.
Our scope is available in the European Commission’s NANDO database.
What does the process look like?
Answer: Here you will find our conformity assessment process according to the MDR.
How long does it take for a notified body to assess a product?
Answer: The timeframe varies depending on the product’s complexity, the notified body’s workload, and the manufacturer’s level of preparation. It can take anywhere from a few months to over a year.
What does it cost?
Answer: See our pricelist.
Where can I find the MDR?
Answer: Regulation (EU) 2017/745.
Which guidelines are relevant to me as a manufacturer?
Answer: There are guidance documents issued by the Medical Device Coordination Group (MDCG), but also guidance documents issued by The European Association for Medical devices of Notified Bodies (TEAM -NB).
Will or have you applied for IVDR?
Answer: RISE MNB is tasked with acting as a notified body for MDR. No decision has been made for IVDR.