Medical Device Reporting
“Each year, FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. With this Medical Device Reporting (MDR) regulation (21 CFR 803) the FDA made all device manufacturer, device user facilities & importers as mandatory reporter, to submit certain types of adverse events reports that may be associated with a medical device, use errors, product quality issues, therapeutic failures to FDA along with data from all available sources to provide critical information that helps/improves patient safety.
Hence, every manufacturer (unless exempted) is required to develop, maintain and implement written MDR procedures that cover all the requirements of the MDR regulation. Also, each MDR files must have a record of each attempt to obtain information.
Being in competitive market, to reduce cost & workload, device companies engage MakroCare for MDR management to have efficient compliance in place at a manageable cost.
To reduce device manufacturer’s workload or augment expertise, MakroCare offers:-
- MDR Reporting resource
- Triage, Interpretation, Writing & Submission of the MedWatch Forms
- Identification of reportable & non-reportable events
- MDR management from other geographical regions
- Guidance in updating each MDR file & 510(k) decisions
- Utilize FDA Maude Database, Enforcement Report, Recall Databases
Levarage MakroCare’s Regulatory & Medical Affairs teams in meeting MDR regulation and compliance.