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MDR Guideline Medical Devices Labeling

This document provides guidelines for medical device labeling in Bahrain. It outlines 14 key pieces of information that must be included on medical device labels, such as the device name, manufacturer name and location, production details, intended use, safety warnings, and sterilization methods. The guidelines reference international standard ISO 15223-1 for symbols used on labels. Correct and clear labeling is important to ensure safe and effective use of medical devices as intended by the manufacturer.

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268 views

MDR Guideline Medical Devices Labeling

This document provides guidelines for medical device labeling in Bahrain. It outlines 14 key pieces of information that must be included on medical device labels, such as the device name, manufacturer name and location, production details, intended use, safety warnings, and sterilization methods. The guidelines reference international standard ISO 15223-1 for symbols used on labels. Correct and clear labeling is important to ensure safe and effective use of medical devices as intended by the manufacturer.

Uploaded by

arade43
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Medical Devices Labeling Guideline

National Health Regulatory Authority (NHRA)

Kingdom of Bahrain

Jan 2020
Version 1.0

E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464


Contents
1. Introduction ................................................................................................... 3
2. Definitions ...................................................................................................... 3
3. Labeling Standard ......................................................................................... 4
4. Label Requirements ....................................................................................... 5

E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464


1. Introduction

This guideline is intended to guide all importers, healthcare facilities and users to the
importance of medical devices labeling. The main aim of correct labeling is to ensure
that the medical devices are used according to the manufacturer’s instructions and not in
a way other than that for which it was intended.
Medical device labeling is intended to assist end-users in understanding the medical
device and assure safe and effective use of it, it gives information about:
• Proper use and adequate directions for operating the medical devices
• Risks, and benefits of the device in language the user can understand
• Recognition, storage, assembly, and troubleshooting.
Labeling is not useful, of course, if it cannot be understood or if it does not
communicate critical information about the medical device to the person trying to use
it.

2. Definitions

Label:
Written, printed, or graphic information either appearing on the medical device itself, or
on the packaging of each unit, or on the packaging of multiple devices.
Symbol on medical device label:
graphical representation appearing on the label and/or associated documentation of a
medical device that communicates characteristic information without the need for the
supplier or receiver of the information to have knowledge of the language of a particular
nation or people.

Labelling:
Includes the label, instructions for use, and any other information supplied by the
manufacturer that is related to identification, technical description, intended purpose and
proper use of the medical device.

E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464


Labeling

(Information Supplied by Manufacturer)

Label Other information


Instruction Information (Technical
for Use intended for description ..etc)
patient

3. Labeling Standard

ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling
that convey information on the safe and effective use of medical devices. It also lists
symbols that satisfy the requirements of this document.
ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices,
which are marketed globally and therefore need to meet different regulatory
requirements.
These symbols may be used on the medical device itself, on its packaging or in the
associated documentation. The requirements of this document are not intended to apply
to symbols specified in other standards.
The use of symbols on the label as an alternative to written language is permitted in the
MDR regulation. Symbols are efficient, cost saving and internationally understood
concepts to convey the required information to the user of a medical device.

E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464


4. Label Requirements

The information required on the label shall be provided on the device itself. If this is not
practicable or appropriate, some or all of the information may appear on the packaging
for each unit, and/or on the packaging of multiple devices.

This information should be provided in a human-readable format and may be


supplemented by with drawings and diagrams to be readily understood by the end-user.

The information on the label should include:

1. Name or trade name of the device.

2. Name and place of the manufacturer.

E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464


3. The label shall contain the details needed to identify the device, the contents of
the packaging and, where it is not obvious for the user, the intended purpose of
the device.

4. Label font should be clear and in Arabic or English.

5. It should indicate the Lot or Serial number (preceded by the words LOT
NUMBER or SERIAL NUMBER or equivalent symbol).
6. The label shall indicate the date of manufacture, this may be included as part of
the lot number or serial number provided the date is clearly identifiable.
7. The label shall bear an indication of any special storage or handling condition
that applies.
8. The label shall indicate (if the device is supplied sterile), its sterile state and
sterilization method.
9. The label shall bear warnings or precautions to be taken that need to be brought
to the immediate attention of the user of the device, and to any other person.
(e.g. CAUTION RADIATION HAZARD)

10. The label shall indicate if the device is intended for single use.

11. The label shall indicate if the device contains or incorporates:


• Medicinal substance
• Human blood or plasma derivative
• Tissues or cells (or derivatives of) of human or animal origin.

12. The label shall indicate if the device is custom made, with the words ‘custom
made device’.

13. The label shall provide an indication that the device is a medical device. If the
device is intended for clinical investigation only, the words ‘exclusively for
clinical investigation’

14. The label shall indicate in the case of devices that are composed of substances
or of combinations of substances that are intended to be introduced into the
human body.
E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464
E-Mail: [email protected] Website: www.nhra.bh Tel.: 17113299 /P.O. Box: 11464

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