EU MDR Notified Bodies
A notified body is an independent organisation designated by an EU member state to assess whether medical devices meet the Medical Device Regulation (MDR 2017/745). For every device above Class I, plus the sterile, measuring and reusable-surgical aspects of some Class I devices, a notified body has to carry out conformity assessment before you can affix the CE mark.
What does a notified body do?
- Audits your quality management system (typically ISO 13485-based).
- Reviews your technical documentation against the MDR.
- Carries out conformity assessment appropriate to your device class.
- Issues the certificate(s) that let you declare conformity and CE mark the device.
Does my device need a notified body?
It depends on your risk class. Every class above Class I needs a notified body. Most Class I devices self-declare, apart from sterile devices, devices with a measuring function and reusable surgical instruments. If you are not sure of your class, work it out first with our MDR classification guide.
How do I find an MDR notified body?
The European Commission maintains the official NANDO database (New Approach Notified and Designated Organisations), which lists every notified body designated under the MDR along with the device scope each one is authorised to assess. It is the authoritative, always-current source, so start there and shortlist the bodies whose designated scope covers your device type.
Health Tech Pathways also lists all Notified Bodies, and will soon also have peer-reviews from other users of Notified Bodies.
How do I choose the right one?
- Scope match: the body must be designated for your device type and technology (for example active devices or software).
- Capacity and lead time: notified body capacity is tight under the MDR, so realistic timelines matter.
- Experience: a track record with devices similar to yours smooths the assessment.
- Practicalities: language, location and cost.
Frequently asked questions
- What is a notified body under the EU MDR?
- A notified body is an independent conformity assessment organisation designated by an EU member state to check whether medical devices meet the requirements of MDR 2017/745. It audits the manufacturer's quality management system, reviews technical documentation and issues the certificates needed for CE marking.
- Does my device need a notified body?
- Every device above Class I needs a notified body for conformity assessment. Most Class I devices can self-declare, apart from sterile devices, devices with a measuring function and reusable surgical instruments, which need a notified body for those specific aspects. Your risk class decides the requirement.
- How do I find an MDR notified body?
- The European Commission maintains the official NANDO database, which lists every notified body designated under the MDR together with the device scope (codes) each one is authorised to assess. Start there, then shortlist the bodies whose designated scope covers your device type.
- How do I choose the right notified body?
- Check that the body's designated scope covers your device type and technology (for example active devices or software). Confirm it has capacity and realistic lead times, which can be long under the MDR. Then weigh experience with similar devices, language, location and cost. Engaging early matters, because notified body capacity is tight.
This page is preparatory guidance based on MDR 2017/745, not legal advice. Always confirm designation and scope in the official NANDO database.
Get ready for notified body assessment
Health Tech Pathways helps you reach a high-confidence classification and prepare the documentation a notified body will expect, and it connects you with notified bodies and regulatory experts.