CE-MDD marking, NBOG Scope Expression and GMDN code
We are a medical device firm and we design and produce spinal implants. We are going towards CE-MDD marking. I'm unclear if we produce class 2b or class 3 medical devices or both. Also, we need to pin down the NBOG Scope Expression, Rule and correct GMDN code. Your help will be greatly appreciated!
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In most certification bodies, the last date for medical devices to be CE marked according to the MDD 93/47/EEC is 1st November. After that date, all new medical devices must be certified according to new Regulation 2017/745 on medical devices (MDR): https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN
For classification, you have to look in Annex VIII of MDR where all rules for classification are. In my opinion, your device is going under Rule 8 for all implantable device, but since they „are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates, and instruments.“ Therefore, if your spinal implants ARE NOT screws, wedges, plates, and instruments, than your spinal implants are class III.
For other questions, I suggest that we talk over Skype or similar services as it will be easier to explain the terms sought.
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Oct 02, 2019