13367 | 14 April 2021 / Preview in attachment
This document provides the requirements for the identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. The aim of this document is to serve as a central source of these common, generally applicable requirements, allowing each specific product standard or group standard to focus more concisely on the unique requirements for a specific medical device or group of medical devices.
The requirements of a medical device product standard or a group standard can make use of these general requirements. Where there is a conflict and a product standard or a group standard exists, this document should not be used separately. Specific requirements of medical device product standards or group standards take precedence over requirements of this document. Unless specified otherwise within a product standard or a group standard, the general requirements of this document apply.
Some authorities having jurisdiction have requirements that can differ from the requirements of this document.
This document has been prepared in consideration of:
- the application of Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N47:2018 on the information supplied by the manufacturer of a medical device (see Annex D);
- the application of Labelling Principles for Medical Devices and IVD Medical Devices, IMDRF/GRRP WG/N52:2019 on the information supplied by the manufacturer of a medical device (see Annex E);
- the application of the essential principles of safety and performance on the information supplied by the manufacturer of a medical device according to ISO 16142-1:2016 (see Annex F);
- the application of the essential principles of safety and performance on the information supplied by the manufacturer of an IVD medical device according to ISO 16142-2:2017 (see Annex F);
- the general safety and performance requirements for the information supplied by the manufacturer of a medical device according to regulation (EU) 2017/745(see Annex G); and
- the general safety and performance requirements for the information supplied by the manufacturer of a medical device according to regulation (EU) 2017/746 (see Annex H).
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true.
In this document, the following verbal forms are used:
- “shall” indicates a requirement;
- “should” indicates a recommendation;
- “may” indicates a permission;
- “can” indicates a possibility or a capability.
Requirements in this document have been decomposed so that each requirement is uniquely delineated. This is done to support automated requirements tracking.
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