Getting MDR certification can feel complex, but breaking it down into clear, structured steps makes the process much easier. This guide will walk you through the essential stages to help you achieve compliance with confidence.
The first step is identifying the correct classification of your medical device under MDR. Devices are categorized based on risk, intended use, and duration of contact with the human body. Correct classification will determine the level of regulatory scrutiny and the type of conformity assessment procedure required.
A robust QMS, typically ISO 13485, is essential. It ensures that your processes, documentation, and risk management practices meet MDR requirements. Establishing procedures for design, manufacturing, and post-market surveillance is key.
Your technical file must include device specifications, risk assessments, clinical data, labeling, and instructions for use. This documentation provides evidence that your device meets safety and performance requirements.
MDR places a strong emphasis on clinical evaluation. Manufacturers must demonstrate the safety and performance of their devices through clinical data, either from trials, literature, or equivalence with existing devices.
For higher-risk devices, a Notified Body must review and approve your conformity assessment. Be prepared for detailed audits, technical file reviews, and possibly on-site inspections.
Once all requirements are met and approved, you can affix the CE Mark to your device. Alongside, issue the EU Declaration of Conformity, officially stating that your product complies with MDR.
Certification is not the end. MDR requires ongoing monitoring of your device’s performance, reporting of adverse events, and continuous improvement of your QMS.
By following these steps carefully, manufacturers can navigate MDR certification with greater clarity and efficiency. Preparation, documentation, and continuous compliance are the keys to success.