**Questions? [[Contact us!]]** The "**conformity assessment**" means the process of demonstrating compliance with the requirements of this Regulation in relation to a device. Before introducing a device to the market, manufacturers are required to conduct an evaluation of the device's compliance, following the relevant conformity assessment procedures outlined in Annexes IX to XI of the MDR. ## Who needs to do the assessment? According to the MDR, manufacturers of Class I medical devices generally have to carry out their own conformity assessment as these devices have a low risk level. This means that the manufacturer himself is responsible for preparing technical documentation and carrying out the required tests to demonstrate that the device meets the applicable safety and performance requirements. For Class IIa, IIb and III devices, a [[Notified Body (NB)]] must be involved in the conformity assessment. In some cases, for a class I device, a notified body may also be involved, for example to provide technical support in drafting the technical documentation or to carry out an assessment of the device. Devices placed on the market in a sterile state, up to the aspects related to the sterile state; Devices with a measurement function, to the aspects related to metrological requirements; With regard to reusable surgical instruments, to the aspects related to reuse, in particular cleaning, disinfection, maintenance, sterilisation and function tests and the associated instructions for use. However, the involvement of the notified body in these procedures is limited. ##### For more requirements see: - Article 52; - Annex IX: Conformity ass;essment based on a quality management system and on assessment of technical documentationl - Annex X: Conformity assessment based on type-examination; - Annex XI: Conformity assessment based on product conformity verification. ## Involvement of Notified Bodies in conformity assessment procedures In cases where the conformity assessment procedure necessitates the participation of a notified body, the manufacturer has the option to request the services of a notified body of their preference, as long as the chosen notified body holds designation for conformity assessment activities relevant to the types of devices in question. The notified body may require any information or data from the manufacturer, which is necessary in order to properly conduct the chosen conformity assessment procedure. ## CE conformity marking Devices, other than custom-made devices or devices for research, which are deemed to conform to the requirements of the MDR shall bear the CE conformity marking. The CE marking must be clearly, legibly, and permanently attached to the device itself or its sterile packaging. If such attachment is not feasible or justifiable due to the device's characteristics, the CE marking should be affixed to the outer packaging. Additionally, the CE marking must appear in any user instructions and on the product's sales packaging. ![[CE.png]] See Article 20 and Annex V MDR