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.
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:
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'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.