IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)

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Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices - PDF (260kb)[附网盘链接]由IMDRF Good Regulatory Review Practices Group于31 October 2018发布，适用于世界。

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Introduction

The purpose of this IMDRF guidance is to provide harmonized Essential Principles that should

be fulfilled in the design and manufacturing of medical devices and IVD medical devices to

ensure that they are safe and perform as intended. The worldwide adoption of a common set of

fundamental design and manufacturing requirements for medical devices that, when met, provide

assurance the device is safe and performs as intended, offers significant benefits to, among others,

manufacturers, users, patients/consumers, and to Regulatory Authorities. Reducing differences

between jurisdictions decreases the cost of gaining regulatory compliance and allows patients

earlier access to new technologies and treatments.

This document has been developed to encourage and support global convergence of regulatory

systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies

(CABs), industry, and other stakeholders, and will provide benefits in establishing, in a

consistent way, an economic and effective approach to the control of medical devices in the

interest of public health. It seeks to strike a balance between the responsibilities of RAs to

safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens

upon the industry.

The manufacturer of a medical device and in vitro diagnostic (IVD) medical device is expected

to design and manufacture a product that is safe and effective throughout its life-cycle. This

guidance document describes fundamental design and manufacturing requirements, referred to as

‘Essential Principles of Safety and Performance’ that, when met, provide assurance that a

medical device and IVD medical device is safe and performs as intended, by the manufacturer.

Essential principles of safety and performance provide broad, high-level, criteria for design,

production, and postproduction throughout the life-cycle of all medical devices and IVD medical

devices, ensuring their safety and performance. Compliance with the Essential Principles of

Safety and Performance, via the use of applicable standards throughout a product’s lifecycle,

including where appropriate a pre-market review, is an acceptable approach for applying controls

relative to a device’s safety and performance by the RAs with Jurisdiction. Depending on the RA

having jurisdiction and the particular medical device or IVD medical device there may be

additional requirements that may need to be met. Where standards are being considered as part

of regulatory compliance, their development can benefit from these Essential Principles of Safety

and Performance.

As used within the context of this document to encourage compliance with the Essential

Principles of Safety and Performance, “should” indicates that among several possibilities, one is

recommended as particularly suitable, without mentioning or excluding others, or that a certain

course of action is preferred but not necessarily required, or that (in the negative form) a certain

possibility or course of action should be avoided but is not prohibited. “May” is used to indicate

that a course of action is permissible within the limits of the standard. “Can” is used as a

statement of possibility and capability. Finally, “must” is used only to describe “unavoidable”

situations, including those mandated by government regulation.

31 October 2018 Page 2 of 35

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