mdr-745-specialist

To classify a medical device under EU MDR 2017/745, apply the classification rules in Annex VIII based on device characteristics, intended purpose, and duration of use. The Skill guides this process to determine the correct MDR class for regulatory compliance.

EU MDR compliance requires technical documentation per Annex II and III, covering device description, risk management, clinical evidence, and labeling. The Skill guides the creation of essential technical files to meet these regulatory requirements.

Yes, EU MDR requires a clinical evaluation strategy and post-market clinical follow-up per Annex XIV. The Skill assists in developing these reports and outlines ongoing safety monitoring requirements for continuous compliance.

Implementing UDI and EUDAMED registration involves assigning Unique Device Identification codes and entering device data into the EUDAMED database. The Skill provides guidance on these steps to ensure proper regulatory tracking.

Yes, the Skill covers risk management according to ISO 14971 as part of the EU MDR 2017/745 compliance process. It integrates risk management requirements into the technical documentation workflow.

The best way to prepare a new diagnostic device for a Notified Body is to classify the product, compile technical documentation per Annex II and III, and plan the clinical evidence strategy. The Skill provides workflows to execute these regulatory steps.