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228 Assurance of sterility for sensitive combination products and materials

Any device incorporating a medicinal product would be classified as a
Class III medical device under the classification rules (Rule 14 of Annex VII
of the Medical Devices Regulation). The manufacturer has to prepare and
sign a declaration of conformity in order to CE-mark the device. In order
to sign such a declaration for a Class III device, the manufacturer would re-
quire certification from a notified body of review of a design dossier or type
test. Both these approaches require the notified body to review the man-
ufacturer’s technical documentation. The requirements for the technical
documentation are set out in Annex II of the Medical Devices Regulation.
Aspects of the technical documentation relevant to claims or sterility are as
follows:
• Design and manufacturing information
(a) information on design and development stages applied to the device;
(b) information and specifications on the manufacturing processes and
their validation;
(c) identification of all sites, including suppliers and subcontractors,
where design and manufacturing activities are performed.
• General safety and performance requirements
Information for the demonstration of conformity with the general
safety and performance requirements that are applicable to the device tak-
ing into account its intended purpose together with justification, validation,
and verification of the solutions adopted to meet those requirements.
The demonstration of conformity includes:
(a) the general safety and performance requirements that apply to the de-
vice and an explanation as to why others do not apply;
(b) the method or methods used to demonstrate conformity with each
applicable general safety and performance requirement;
(c) the harmonized standards or other solutions applied; and.
(d) the documents providing evidence of conformity with the harmonized
standard or other method applied to demonstrate conformity with the
general safety and performance requirements.
Notified bodies offer pre-submission meetings where the rationale for
decisions made in regards to assurance of sterility could be discussed.

9.4 FDA guidance on labeling devices as sterile

The FDA has published guidance specifically for information to be pro-
vided in 510(k) submissions for devices labeled as “sterile.” This document
was published in 2016, and is entitled “Submission and Review of Sterility