IMDRF/PMD WG/NSSFINAL:2020 Personalized Medical Devices - Regulatory Pathways - PDF (612kb)

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1.0 Introduction

The purpose of this IMDRF guidance is to recommend a harmonized approach for the

application of existing regulatory pathways to medical devices that are intended for a particular

individual, and to identify special considerations for the regulation of each identified category of

personalized medical device. The adoption of consistent, harmonized requirements for such

medical devices will underpin a harmonized regulatory approach for controls on these types of

medical devices and offer significant benefits to the manufacturer, user, patient, and to

Regulatory Authorities. Eliminating differences between jurisdictions supports global

convergence, reduces the cost of gaining regulatory compliance and allows patients and

healthcare professionals earlier access to new treatments and technologies. This document

includes an overview of some of the considerations and concepts that may be relevant in

developing a harmonised assessment approach in future.

Technology has progressed from the time the original Global Harmonization Task Force (GHTF)

foundation documents were published. It is now possible to produce medical devices that are

individualized on a commercial rather than artisanal scale. Manufacturing technologies used to

create these personalized medical devices include computer-controlled additive and subtractive

manufacturing methods based on patient images. The original GHTF documentation does not

adequately address medical devices of this nature.

Many jurisdictions already define the term custom-made device and have introduced exemption

provisions for regulating custom-made medical devices, with the intention of covering special

cases where commercially available products or alternative therapies are inadequate for the needs

and requirements of a particular individual. In some jurisdictions, the exemption provisions

were based on the premise that affected devices would largely comprise low-risk products or

limited use of higher-risk implantable devices. In other jurisdictions, the exemption provisions

were established with the intention that numbers of manufactured custom-made devices would

necessarily be small, due to the requirement for them to be used only in special cases.

Now regulators are faced with a very different environment. Technologies such as additive and

subtractive manufacturing (see Appendix 1), especially when combined with digital patient data,

have made “custom-made” devices, including implantable devices for particular patients, within

reach on a much greater scale. Advancing technology has also enabled a shift to point-of-care

manufacturing (see Appendix 2). Regulations were not necessarily designed to address this form

of manufacturing and, consequently, some jurisdictions are noticing questionable use of custom-

made device exemption pathways for higher risk classification medical devices. Growing

numbers of patients are receiving these medical devices, to meet their particular needs, without

there being adequate regulatory oversight in place.

Note: This document is intended to provide a best-practice model for suitable regulatory

pathways for different types of personalized medical devices, and is intended to assist with

harmonizing the regulation of personalized medical devices across international jurisdictions.

Individual jurisdictions may have particular requirements in place, which pre-date this guidance

or that are more specific than this guidance, for some or all of the device categories represented.

18 March 2020 Page 4 of 22

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