Conformity Assessment
Conformity assessment is the process by which it is demonstrated that a medical device meets the applicable regulatory requirements of the EU MDR or IVDR. Depending on the risk class of the product, it involves an internal assessment by the manufacturer and/or an assessment by a Notified Body. The procedure includes review of technical documentation, the quality management system, and the clinical evaluation. Upon successful completion, the manufacturer may affix the CE marking.
The conformity assessment procedure also verifies whether the instructions for use are available in all required languages and meet the regulatory requirements for content and comprehensibility.
Frequently Asked Questions
What role do IFU translations play in the conformity assessment procedure?+
The completeness and correctness of IFU translations are part of the verification of general safety and performance requirements under EU MDR Annex I. The Notified Body may require sample language versions to be submitted during conformity assessment, and deficiencies in translation can lead to refusal or suspension of the certificate.