Biomedical Engineering Reference
In-Depth Information
conformity when placed on the European market. In the effort to demonstrate
conformity with the essential requirements, the manufacturer must determine the
classification of the medical device. The device classification determines the
conformity assessment procedures available to the manufacturer.
Advanced biomaterials for the treatment of skin loss may contain collagen or
other components derived from material of animal origin. Section 4.5, Rule 17 of
Annex IX of the MDD
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concerning device classification provides that 'All
devices manufactured utilizing animal tissues or derivatives rendered non-viable
are Class III except where such devices are intended to come into contact with
intact skin only.'
According to this rule, the majority of collagen medical devices are considered
Class III in the European Union. Article 11 of the MDD provides the conformity
assessment procedures. There are two alternative procedures provided for Class III
devices. The first procedure, the most commonly used procedure for Class III
devices, is detailed in Annex II of the MDD. Under this procedure, the manufac-
turer must obtain the applicable ISO 13485:2003
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certification of their Quality
System from a Notified Body (chosen by the manufacturer) to the current ISO
standard, which is currently ISO 13485:2003. In addition, the manufacturer must
submit a design dossier for examination by the Notified Body. The design dossier
must demonstrate conformity with the essential requirements and describe the
design, manufacture and performance of the product in question. Upon approval
from the Notified Body, the manufacturer may apply CE marking to the device.
The second procedure, EC type-examination, is available for companies that do
not have an ISO 13485:2003 certified quality system. It involves verification by
the Notified Body that samples conform with the essential requirements and
product design specifications. Depending on the depth of the manufacturer's
quality system, continued monitoring is achieved either by examination and
testing of samples from every batch or by periodic inspection and assessment.
Because of the requirements for continued testing and inspection by the Notified
Body, the first procedure for conformity assessment is preferred for products
produced frequently, with a great number of batches.
7.3.2
Medicinal product approval in the European Union
There are currently two systems for medicinal product approval in the European
Union: a decentralized approval on the national level and a centralized approval
from the European Agency for the Evaluation of Medicinal Products (EMEA).
The decentralized system relies on the principal of mutual recognition of
national authorizations. The process involves obtaining approval from the national
authority of a member state in the European Union and that approval is then
extended to other member states as identified by the applicant. However, if the
original national authorization is not recognized by the secondary member state,
the dispute is submitted to the EMEA for arbitration.
