A Notified Body is an entity that has been accredited by a Member State of the European Union to be responsible for assessing conformity to the applicable regulatory medical device requirements.
Medical device companies that wish to sell products into Europe must establish a relationship with a Notified Body, a private company whose role is to perform conformity assessments of new medical device products entering the European marketplace. Notified Bodies assess the conformity of medical device products against the appropriate directive - either the European Medical Devices Directive (MDD) 93/42/EEC, the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC or the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC.
Notified Bodies may perform conformity assessments in a variety of ways before issuing a CE marking, and the particular pathway will depend on the choices of the manufacturer and the device risk classification that has been assigned to the product.
Notified Bodies and the CE Marking Process
In the European Union, medical devices that have clearance to be sold must be affixed with a CE marking that symbolizes their conformity with the appropriate directives. Notified Bodies have been accredited by a Member State of the EU as the designated entity to govern the CE marking process and must be contracted by medical device manufacturers to perform a conformity assessment prior to market entry.
The CE marking process conducted by a Notified Body can be summarized as follows:
- Determine which European directive applies to your medical device
- Determine the risk classification of your device (Class I, IIa, IIb or III)
- Implement a quality management system (QMS) for your medical device in compliance with ISO 13485, if required.
- Compile the information gathered in your medical device QMS into technical documentation whose goal is to demonstrate your product conformity to the applicable medical device directive. Follow the Summary Technical Documentation (STED) format.
- Prepare a Clinical Evaluation Report in compliance with the applicable medical device directive.
- If your manufacturing facility is located outside Europe, you must appoint an authorized representative in Europe to act on your behalf.
- Have your QMS audited by a Notified Body. If yours is a Class III medical device, you must also have your technical documentation assessed by the Notified Body. If your medical device passes these assessments, you will receive an ISO 13485 certificate and a CE marking certificate.
- Prepare a Declaration of Conformity, stating your compliance with the appropriate directives.
Notified Body Conformity Assessments in the EU MDR
The new EU MDR does not go into effect until May 26th, 2020. Under Annexes IX, X and XI of the new regulation, a Notified Body may perform a conformity assessment based on a quality management system and assessment of the technical documentation, based on type examination, or based on product conformity verification. Manufacturers can now choose from several regulatory pathways to obtain a CE marking, but will still be required to demonstrate compliance with the ISO 13485 medical device quality standard.
Greenlight Guru Facilitates Notified Body Conformance Audits
Greenlight Guru's medical device QMS software is purpose-built to help medical device manufacturers comply with the medical device quality standards set forth in ISO 13485 and FDA 21 CFR Part 820. The cloud-based platform offers a fully integrated multi-level design control, risk and document management feature set that streamlines the audit process, providing an easy track to obtain CE marking and reduce your time to market.