Role of Notified Bodies
A notified body (NB) is an organization in charge of the conformity assessmentof medical devices before they are placed on the market or put into service. It also makes sure that requirements are met as long as the product remains on the market.
Therefore, a notified body works with manufacturers who wish to make medical devices available to patients and users on the European Market.
In order to access European market, manufacturers shall complete appropriate actions allowing them to to sell their medical devices. These actions include obtaining one or more CE marking certificates, which attest devices conformity to European regulatory standards.
This authorization is granted by the notified body, which is an organization permitted by its national competent authority, to perform conformity assessment activities covered by its designation.
Depending on the device(s) nature and the company’s strategy to set up a complete quality management system or not, the notified body performs services intended to verify whether the manufacturer is successfully meeting applicable requirements.
Any organization wishing to obtain notification to become a notified body must apply to its national competent authority. Each national authority is in charge of the notified bodies established on its territory.
The national authority analyzes the application and conducts assessments to make sure that the applicant notified body meets specific applicable requirements.
The obligations that notified bodies must fulfill are laid out in European regulations including the following items:
- Independence, impartiality, and confidentiality when dealing with manufacturers and economic operators;
- Competence and professional integrity;
- Understanding of regulatory requirements and implementation of related processes;
- Implementation of a quality management system that covers conformity assessment activities.
If the assessment is successful, the national competent authority designates the organization as a notified body and defines the scope of its activities. This scope is determined based on the notified body’s competence and ability to perform services.
The national competent authority monitors and reassesses notified bodies periodically in order to ensure that they are still meeting their obligations.
Once designated, the notified body can only work within the scope determined by the designation. It is not authorized to offer consulting services, opinions or strategies to a company with regard to product design, manufacturing, construction, marketing, or maintenance of devices or processes.
As a French notified body, GMED is designed and authorized to perform conformity assessments on a wide range of medical devices under:
- European Regulation (EU) 2017/745 – Medical Devices
- the following European Directives:
– 90/385/EEC as amended by Directive 2007/47/EC – Active Implantable Medical Devices (AIMD)
– 93/42/EEC as amended by Directive 2007/47/EC – Medical Devices (MD)
– 98/79/EC – In Vitro Diagnostic Medical Devices (IVDMD)
The full range of GMED’s activities is available on the official European Commission website via the NANDO (New Approach Notified and Designated Organisations) information system.
GMED’s designation process under Regulation (EU) 2017/746 is underway.
When a manufacturer submits a certification application, GMED analyzes the application to confirm that it can offer its services as a notified body. GMED verifies that the conformity assessment chosen by the manufacturer is appropriate for the device that is the subject of the application.
Based on which conformity assessment procedure the manufacturer uses, GMED then performs the activities required by regulation to check whether the requirements are being met.
Services are performed by independent, competent, qualified and trained personnel under GMED’s responsibility. Their competences are maintained taking into account changes to regulations and standards, but also through experience acquired over many years.
The decision to certify is completely impartial, based on concrete evidence and the results of the assessments conducted, by a committee constituted of multiple GMED team members independent from the case.
After issuing the certificate(s), GMED is responsible for monitoring the manufacturer by conducting surveillance activities to ensure that it continues to meet regulatory requirements. To that end, GMED performs services as required by applicable regulations.
During this monitoring, and depending on the assessment results, GMED, in its role as a notified body, maintains, suspends or withdraws the certificates issued.
On request, the notified body may assess the conformity of new devices or assess conformity after a device or quality management system has changed.
Find out more information on our web page on CE Marking and consult our GMED standard rates applicable to services in the framework of Regulation (EU) 2017/745 (applicable rates for activities managed by our European offices).
The notified body is required to regularly report to its national competent authority on certificates issued, modified, withdrawn or suspended.
The national competent authority or any other competent authority may also contact the NB about devices for which the NB issued, withdrew, or suspended a certificate. The NB must provide these authorities with any requested information that is in its possession.
Before applying for certification, the manufacturer must identify the notified body that is able to assess the conformity of its product for CE marking purposes.
NB scope of notification
An NB is notified for some or all conformity assessment activities within the framework of one or more European regulations. NB notification does not systematically cover all medical devices. The notified body must be designated for conformity assessment procedures and for the devices that are the subject of the manufacturer’s application.
This means that an NB’s activities vary based on:
- the regulations or directives for which it is notified, and
- the scope of notification and the corresponding product codes.
You can search the list of notified bodies on the European Commission’s NANDO (New Approach Notified and Designated Organisations) informational website. This database includes all information about NB: the regulations and directives under which they can operate, the activities for which they are notified, and the devices covered by the NB’s scope.
NB reputation and ethical commitment
An NB’s reputation is often a reflection of how it operates and its ethical commitment.
Membership in a recognized association promoting high standards of practices for notified bodies is sign of quality for an NB.
This is why GMED is a member of the Team-NB association and works with other notified bodies to establish best practices, promote technical and ethical standards and participate in developing a legal framework.
Notified body guidance documents fall into one of three categories:
- those published by notified bodies themselves (NB-MED),
- those adopted by the European Commission as official guidance documents: “MEDDEV” for Directives on medical devices and MDCG guidance documents for Regulations on medical devices, and
- those published by the Notified Body Operations Group (NBOG), for which guidance documents are primarily aimed at notified bodies.
The links to the three sets of documents are below.
- NB-MED documents: http://www.team-nb.org/nb-med-documents/
- MDCG documents: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_fr
- NBOG documents: https://www.nbog.eu/nbog-documents/
Our teams of experts, dedicated to the health care and medical devices industry, and our proven practices make GMED among the leading companies at an international level.
GMED is a well-known notified body thanks to its experience and state of the art knowledge of all types of medical devices.