European Medical Device Regulation (MDR) requires manufacturers to prepare detailed Technical Documentation to obtain and maintain CE Marking of medical devices. In most cases, this documentation will be reviewed by your European Notified Body and contains a wide array of information about your device: specifications, manufacturing process, design controls, test reports, risk assessments, clinical data, and much more.
Quick Facts About EU MDR Technical Documentation:
- Technical Documentation is the new name for Technical Files and Design Dossiers.
- It is required for all classes of medical devices.
- Technical documentation includes documentation from post-market surveillance too.
- MDR Annex II and Annex III outline basic documentation requirements.
- Some Notifed Bodies have issued their own guidance for technical documentation submissions
Gap Assessment and Strategic Advice for Compliance with Current MDR Requirements
Many manufacturers seeking CE Marking for devices already have some of the information required. Nonetheless, it can be overwhelming to figure out exactly what is needed under the EU MDR, and whether what you have is acceptable to your Notified Body. Our team of consultants includes ex–Notified Body reviewers who can perform a detailed review of your existing documentation. We can identify the gaps and weaknesses, and prepare a plan outlining the procedures, documentation and testing you need in order to prepare MDR-compliant technical documentation. If you are transitioning an existing MDD-certified device to the EU MDR, we can conduct a thorough assessment of your current technical file or design dossier so you know where to focus your efforts prior to your next Notified Body audit. For manufacturers with large product portfolios, we can also provide strategic advice for transitioning your devices to the MDR.