Page 249 - Assurance of Sterility for Sensitive Combination Products and Materials

226 Assurance of sterility for sensitive combination products and materials

integral product are concerned. Furthermore, the application for a market-
ing authorization has to include either:
• a manufacturer’s declaration of conformity or relevant certificate from a
notified body designated under the Medical Devices Regulation allow-
ing the manufacturer to CE-mark the device, supplied on its own, under
this regulation; or,
• an opinion on the conformity if the device part with the relevant
general safety and performance requirements of the Medical Devices
Regulation, provided by a notified body designated under the Medical
Devices Regulation.
Any device that incorporates as an integral part a substance with an
action ancillary to that of the device which, if used separately, would be
considered to be a medicinal product, including a medicinal product de-
rived from human blood or human plasma, is assessed and authorized in
accordance with the Medical Devices Regulation. Such a product would
be categorized as a Class III device and require review by a notified body
designated under the regulation. As part of the process of review to obtain
that certificate, this notified body would consult with a competent author-
ity for medicinal products in one of the EU member states in regards to the
safety, quality, and usefulness of any substance considered to be a medicinal
product.
Other changes brought in by the Medical Devices Regulation affect
gaps in coverage of the Advanced Therapy Medical Products Regulation
[Regulation (EC) No 1394/2007] and Directive 2004/23/EC regarding
human tissues and cells. Any product containing human material was ex-
cluded from the Medical Devices Directive. Products manufactured utiliz-
ing derivatives of tissues or cells of human origin that are nonviable or are
rendered nonviable now come under the scope of the Medical Devices
Regulation if they meet the definition of a medical device.

9.3.2 Marketing authorization as a medical product
Applications for market authorization as a medicinal product could be
made by a centralized procedure through the EMA or a decentralized
procedure through national competent authorities, depending on the
nature of the medical product and the market strategy of the applicant
for market authorization. The procedures and methods applied to assure
sterility of the product would be detailed in the portion of the submis-
sion generally referred to as the Chemistry, Manufacturing, and Controls
(CMC) section.