CFR section
21 CFR 803.18(e): What are the requirements for establishing and maintaining MDR files or records that apply to me?
PART 803-MEDICAL DEVICE REPORTING · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 803.18(e) |
|---|---|
| Section | What are the requirements for establishing and maintaining MDR files or records that apply to me? |
| Part | PART 803-MEDICAL DEVICE REPORTING |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (e) If you are a manufacturer, you may maintain MDR event files as part of your complaint file, under part 820 of this chapter, if you prominently identify these records as MDR reportable events. We will not consider your submitted MDR report to comply with this part unless you evaluate an event in accordance with the quality system requirements described in part 820 of this chapter. You must document and maintain in your MDR event files an explanation of why you did not submit or could not… |
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