Page 250 - Assurance of Sterility for Sensitive Combination Products and Materials

Regulatory pathway for labeling combination products as sterile 227

The review of the submission would consider the sterility requirements
in relation to the applicable monographs of the European Pharmacopeia.
Any submission that did not follow the European Pharmacopeia’s expecta-
tion of terminal sterilization achieving a maximal sterility assurance level of
−6
10 would be subject to individual review.
Competent authorities for medicinal products and the EMA offer
pre-submission meetings where the rationale for decisions made in regard
to assurance of sterility could be discussed.

9.3.3 CE-marking for a medical device
The regulatory system for medical devices offers a variety of routes for
conformity assessment based on the risk classification of the medical device
and the strategy for regulatory compliance developed by the manufacturer.
All devices, irrespective of their risk classification, have to meet the gen-
eral requirements for safety and performance that apply to them. In terms
of sterile devices, the applicable requirements are that the device:
(a) is designed, manufactured, and packed in a nonreusable pack and/or
according to appropriate procedures to ensure that it is sterile when
placed on the market and remains sterile, under the storage and trans-
port conditions laid down, until the protective packaging is damaged or
opened;
(b) is manufactured in appropriately controlled environmental conditions;
(c) is manufactured and sterilized by an appropriate, validated method;
(d) is labeled with the word ‘STERILE’ or an accepted symbol indicating
sterility;
(e) has packaging and/or labeling that distinguishes between identical or
similar product sold in both a sterile and a non-sterile condition.
The regulatory requirements for devices indicate that devices, systems,
or processes that are in conformity with relevant harmonized standards are
presumed to be in conformity with those requirements of the regulations
covered by those standards. References to standards that are considered to
be harmonized are published in the Official Journal of the European Union.
The list of harmonized standards under the Medical Devices Directive in-
cludes standards identifying requirements for terminally sterilized medical
devices to be designated sterile, EN 556-1, and the European adoptions of
international standards for the development, validation, and routine control
of sterilization by the methods of sterilization generally applied for terminal
sterilization. It is expected that these same standards will be given the status
of harmonized under the Medical Devices Regulation.