A company recently received the following observation:
…..Written MDR procedures have not been developed, maintained and implemented.
Specifically, you failed to develop and implement written MDR procedures as the manufacturer of medical devices.
According to the Code of Federal Regulations (21 CFR 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us;
(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
(4) Systems that ensure access to information that facilitates timely follow-up and inspection by us.
According to GMP Trends® Annual Reports, over the last 5 years the observations pertaining to equipment cleaning (21 CFR 803.17) has been in the top 5 observations cited by the FDA each year.
For more information on medical device reporting, refer to the following FDA guidance documents, Medical Device Reporting for Manufacturers and Medical Device Reporting (MDR): How to Report Medical Device Problems.
Stay in Compliance! Subscribe today!