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IMDRF/RPS WG/N19 FINAL:2016 Common Data Elements for Medical Device Identification - PDF (747kb)

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标准简介

Common Data Elements for Medical Device Identification - PDF (747kb)[附网盘链接]由IMDRF RPS Working Group于24 March 2016发布，适用于全球。

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Common Data Elements for Medical Device Identification - PDF (747kb)[附网盘链接]
Common Data Elements for Medical Device Identification - PDF (747kb)[附网盘链接](截图)

 

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标准部分原文

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1 Introduction

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011

as a forum to discuss future directions in medical device regulatory harmonization. It is a

voluntary group of medical device regulators from around the world who have come together to

build on the strong foundational work of the Global Harmonization Task Force (GHTF). The

Forum will accelerate international medical device regulatory harmonization and convergence.

Regulators require submission of device identification information at different points in the

regulatory life cycle of a medical device. Structured device identification information is now or

expected in the future to be included as part of pre-market submission, post-marketing

distribution and use (disposal and discard), adverse event/vigilance reporting, and recall.

Once the medical device is commercially available, a Unique Device Identification (UDI) system

is expected to capture the device identification data elements at the level of a particular medical

device. However, at the point of initial regulatory submission, specific medical device

identification data elements are not always assigned. Therefore it would be useful to establish

common data elements, for which they can be defined throughout the life cycle. Currently these

data elements have not been identified resulting in the lack of a consistent nomenclature,

definitions and structure for submission of this identifying information. Each type of submission

may reference the product differently. For example, a regulatory submission may refer to the

medical device’s trade name, the data attributes associated with UDI may contain brand name

and a recall may refer to proprietary name – all referring to the same medical device. The

identification information is also often submitted as part of unstructured medical device

regulatory submission forms and other unstructured documents. The combination of different

ways to identify a medical device and the unstructured way medical device information is

submitted make it difficult over time to reconcile references to the same medical device.

Inconsistency in the format used to identify medical devices as part of submissions and the lack

of a harmonized nomenclature and structure for medical device identification information,

currently result in multiple submissions of data, inconsistencies in submitted information, and

ultimately an inability to compile effective market surveillance information about a medical

device. Lack of a common definition for medical device identification information also

increases the risk that, for regulatory purposes, a medical device may be referenced differently in

different countries, which limits the ability to compile data or make comparisons across

countries.

Consistent use of standardized structured data elements for submission of regulated medical

device identification information will aid in long-term regulatory convergence by providing a

common way for regulators to refer to what is regulated and enables tracking and reporting

unambiguously on the regulatory marketing status of a medical device around the world.

24 March 2016 Page 5 of 17

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