What is Notified Body?
In the European Union, a notified body for medical devices is an organisation that has been appointed by an EU member state to assess the conformity of medical devices before that device can be placed on the EU market.
Notified bodies perform conformity assessment procedures laid out in the EU directives or regulations that are applicable to medical devices.
What is a Conformity Assessment?
Conformity assessment, in general, is the procedure by which the conformity of a product is assessed before it is placed on the EU market. The manufacturer needs to demonstrate that all legislative requirements are met and this is done through the conformity assessment procedure. Conformity assessment also serves to ensure the confidence of consumers, public authorities and manufacturers regarding the conformity of products. Depending on the Medical Device class, an appropriate conformity assessment procedure must be followed, as prescribed in the medical device legislation.
How do Notified Bodies perform a Conformity Assessment?
Generally, Notified Bodies are free to offer their conformity assessment services inside or outside the EU. Even though Notified Bodies are designated by a specific member state, they may also conduct their conformity assessment activities in the territory of other EU countries or non-EU countries, if they are officially designated or recognized by the regulatory authority of that country.
Notified Bodies must operate in a non-discriminatory, transparent, neutral, independent, and impartial manner and must employ the necessary personnel, with sufficient knowledge and experience to carry out the conformity assessment in accordance with the relevant legislation.
Notified Bodies must ensure the confidentiality of the information obtained in the course of a conformity assessment and must be adequately insured to cover their professional activities, unless liability is assured under the national legislation of the notifying EU country. Finally, notified bodies must provide requested information to their notifying authority, the market surveillance authorities, and other notified bodies.
Notified Bodies for the CE Mark
The EU MDR requires that all medical devices must be labelled with a CE marking before they are made available on the EU market. This mark indicates that the manufacturers has stated that the medical device complies with all relevant requirements of EU legislation and guarantees a safe and effective medical device.
Whether notified bodies are involved in the conformity assessment procedure, depends on the risk class of the medical device. According to the MDR, certain Class I devices (i.e. Is, Im, and Ir), all Class IIa, all Class IIb and all Class III medical devices require that a notified body must be involved in the conformity assessment procedure.
After the notified body has completed the conformity assessment of the product with the relevant requirements of the applicable EU legislation, it will issue the appropriate certificate (e.g. an EC or EU type-examination certificate).
If a medical device has been assessed by a notified body, then the CE mark must be followed by the 4-digit identification number for the notified body, i.e. NB XXXX.
All accredited notified bodies are listed in an online database. The Nando (New Approach Notified and Designated Organisations) Information System can be searched and allows for validation of the status of the “notification” of a notified body for specific regulations and directives.
Notification is the action that an EU member state takes to inform the European Commission and other member states that a body fulfils the relevant requirements, and has been designated to perform conformity assessment activities according to specific regulations and directives.
You can find a list of notified bodies for medical devices in the Nando Information System.
How are the Notified Bodies controlled?
The EU MDR specifies that each member state shall designate a Competent Authority that will be responsible for implementing the MDR. The Competent Authority is also responsible for designating Notified Bodies, to act as independent third party assessors of the manufacturer’s compliance. The Competent Authority verifies the competence of notified bodies at regular intervals following the practice established by the accreditation organisations.
Can Medical Device Companies choose a Notified Body by themselves?
Manufacturers are free to choose any notified body that has been legally designated to carry out the conformity assessment procedure.
If you would like to find out more about notified bodies, either to determine if you need one for your conformity assessment or if you need help finding one, please contact our team at firstname.lastname@example.org.