§ 803.57 - Annual certification.

(a) All manufacturers required to report under this section shall submit an annual certification report to FDA, on FDA Form 3381, or electronic equivalent as approved under § 803.14. The date for submission of certification coincides with the date for the firm's annual registration, as designated in § 807.21 of this chapter. Foreign manufacturers shall submit their certification by the date on which they would be required to register under § 807.21 of this chapter if they were domestic manufacturers. The certification period will be the 12-month period ending 1 month before the certification date, except that the first certification period shall cover at least a 6-month period from the effective date of this section, ending 1 month before the certification date.

(b) The manufacturer shall designate, as the certifying official, an individual with oversight responsibilities for, and knowledge of, the firm's MDR reporting system. A manufacturer may determine, based upon its organizational structure, that one individual cannot oversee or have complete knowledge of the operation of the reporting system at all organizational components or manufacturing sites owned by the firm. In this circumstance, the firm may designate more than one certifying official, each of whom will sign a certification statement pertaining to his/her respective identified organizational component(s) or site(s), provided that all organizational components and sites are covered under a certification statement.

(c) The report shall contain the following information:

(1) Name, address, and FDA registration number or FDA assigned identification number of the reporting site and whether the firm is a manufacturer;

(2) Name, title, address, telephone number, signature, and date of signature of the person making the certification;

(3) Name, address, and FDA registration number or FDA assigned identification number for each manufacturing site covered by the certification and the number of reports submitted for devices manufactured at each site;

(4) A statement certifying that:

(i) The individual certifying for the firm has read the MDR requirements under this part;

(ii) The firm has established a system to implement MDR reporting;

(iii) Following the procedures of its MDR reporting system, the reporting site submitted the specified number of reports, or no reports, during the certification period; and

(iv) The certification is made to the best of the certifying official's knowledge and belief.

(d) The name of the manufacturer and the registration number submitted under paragraph (c)(1) of this section shall be the same as the reporting site that submitted the reports required by §§ 803.52, 803.53, and 803.55. Multireporting site manufacturers who choose to certify centrally must identify the reporting sites, by registration number and name covered by the certification, and provide the information required by paragraphs (c)(2) and (c)(3) of this section for each reporting site.