Conformity Assessment
The process by which a manufacturer demonstrates that a medical device meets the applicable regulatory requirements. Under EU MDR, conformity assessment involves a Notified Body review for higher-risk devices and covers quality management, technical documentation, and clinical evidence.
Conformity assessment is the systematic evaluation that proves a medical device complies with all relevant regulatory requirements before it can be placed on the market. Under EU MDR 2017/745, the type of conformity assessment depends on the device's risk classification.
Routes under EU MDR
Class I devices follow a self-declaration route — the manufacturer compiles a Technical File and issues a Declaration of Conformity without Notified Body involvement (except for sterile or measuring devices). Class IIa, IIb, and Class III devices require progressively more rigorous Notified Body oversight, including full Quality Management System audits, Technical Documentation reviews, and clinical evidence evaluation.
Relevance to procurement
When responding to EU tenders, suppliers must demonstrate that their device has undergone the correct conformity assessment route for its risk class. Procurement teams verify the Notified Body certificate number, the conformity assessment Annex used (e.g., Annex IX, XI), and the validity dates. Devices assessed under the wrong route — or with expired certificates — will be rejected during technical evaluation.