CE Marking for Medical Device Software
Following the release of the EU Medical Device Regulation (MDR) in May 2021, software can now be classified as active medical device.
As such, if traded in the EU Market, Medical Device Software is required to have the CE marking.
Regardless of the class of the device, all devices are required to be CE marked except when they are intended for clinical investigations. Responsible for the CE marking are the SaMD manufacturers irrespective of the manufacturing process being outsourced or not.
Conformity assessment, a must?
Not all SaMD are subject to rigorous conformity assessments conducted by Notified Bodies. For SaMD not belonging to classes IIa, IIb and III a graduated system of control is more appropriate considering that their level of potential hazard is not applicable. When the assessment of a Notified Body becomes compulsory, the Quality Management System (QMS) will be audited to determine its compliance with the regulatory obligations. Once the QMS is assessed and its conformity with the relevant requirements is determined, the Notified Body will grant the organization an EU QMS certificate. The last steps before releasing it to EU Market, are completing the declaration of conformity and registering the product in the EUDAMED Database.
Instructions for use
While it is expected that instructions for use are provided for the devices, in cases when they can be used safely and the manufacturer can demonstrate the safe and effective use of the device, instructions for use of the product are not mandatory (Annex I, Section 23.1(d)).
EUDAMED Database
Managed by the European Commission, the European Database for Medical Devices (EUDAMED) captures all relevant information on medical devices placed on the EU market. EUDAMED is part of the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements and aims to foster transparency and traceability of medical devices throughout their lifecycle. While the EUDAMED is a European database, patients worldwide will be able to access the public information.