Notified bodies are government accredited, mostly private companies that take over sovereign tasks on behalf of national authorities.
Definition: Conformity Assessment Body and Notified Body
„‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;
‘notified body’ means a conformity assessment body designated in accordance with this Regulation;“
E.g. typical tasks of notified bodies include:
- Certifying quality management systems according to ISO 13485 and to the Annexes of MDD respectively MDR
- Performing "type examinations"
- Reviewing technical files such as risk management files, software files and usability files, and checking compliance with legal requirements
- Assessing clinical evaluations
That means that notified bodies such as the TÜVs act decisively on the "approval" (a conformity assessment by the manufacturer itself) of medical devices.
The balancing act, that the notified bodies have to deal with, is that on the one hand they are in competition with each other and might be tempted by winning customers (the Medical Device Manufacturers) through generous checks.
On the other hand, they are being checked themselves (in the past (too) laxly) by the authorities and must therefore ensure that no safety-critical products are placed on the market.
Find Notified Bodies
If you need an overview of the notified bodies (in Germany), please check out the website of the DIMDI, the German Institute for Medical Informatics, a government organization belonging to the German Ministry of Health.
Additionally, the EU website is recommended. This site will not only help in the search for countries, but also in the search for the directives, which the Notified Bodies are accredited for.
For more information, you can check out this site about notified bodies in EU and their "accreditation scope".
Notified Bodies FAQ
- Q: Do you recommend any notified body in particular?
A: The Johner Institute works well and trustfully with all notified bodies. Most of the notified bodies recommend our services.
As not all notified bodies are competent in all subject matters, we have to know more about your products in order to give a more specific recommendation. Do not hesitate to contact us.
- Q: Are there any differences in how demanding notified bodies enforce compliance with the regulations?
A: The differences between auditors of one notified body are more significant than the differences between the notified bodies.
- Q: Are there any differences with respect to costs?
A: Yes. Notified bodies are companies in a competitive environment. There are not obligations by government with respect to pricing. Therefore, we strongly encourage you to ask for a bid to compare the prices. Please make sure that the quotes are actually comparable. Let us know if you are looking for help.
- Q: Do I need a notified body at all? If yes, under with circumstances?
You always have to involve a notified body in the medical device approval process if your product does not fall into class I. Many notified bodies also operate testing labs. However, not all testing labs (e.g. usability or electrical and electro-magnetic safety) are notified bodies.
- Q: How long does it take until a notified body is auditing our quality management system?
A: A reliable answer is difficult. There are unfortunately notified bodies not even responding to customer requests. We also experienced situations when the notified body called back the very same day.
Generally speaking, it will take three to nine months between initial contact with the notified body and certification of the quality management system.
Please be aware that the number of notified bodies decreases, increasing the workload of the remaining notified bodies. This unfortunately also increases lead and response times.
Please be aware that there are institutions with accreditation to certify quality management systems, even according to ISO 13485. However, some do not have an accreditation to certify according to MDD respectively MDR. This is the exclusive right of notified bodies.