Medical Device Labeling

Medical Device Labeling is complex and needs appropriate information and knowledge on how and what and, what should communicate with users via labels or IFU or Manuals.

MDD 93/42/EEC Annex 13.1 states each device must be accompanied by the information needed to use it safely and properly taking account of the training and knowledge of the potential users of the medical device manufactured and sold by your firm.

MDR 2017/745 sec 23.1(a) states the medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose, and the technical knowledge, experience, education or training of the intended user(s).

In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams wherever applicable by the medical device manufacturer.

Medical Device Labeling Requirements

It’s understood that the new EU regulation for medical devices will have major implications for the labeling operations of every manufacturer that trades in the EU. The definition of ‘label’ in MDD to include Instructions for Use and user manuals only but in EU MDR introduces additional requirements that need to be included on primary, secondary & tertiary sticky labels or non-sticky medical device labels forcing organizations to design information panels.

Manufactures must understand it’s both a design and a data challenge, and must quickly be addressed before the extended dates of MDR 2017/745 entry on May 2021.

Medical Device Symbol to indicate the device is a medical device.
Significant label redesign to adjust spacing differences to accommodate warning & precautions.
Method of supply of instructions for use must be provided on the packaging for each unit and for fixed medical devices, on-device itself.
Display of URL for accessing eIFU
Single-use devices must detail the maximum possible time that can be reprocessed as well as the number of times the individual device has been reprocessed to date.
Devices with a presence of carcinogenic, mutagenic, or toxic to reproduction (CMR) substances must declare on the label.
All devices that incorporate a medical substance or tissues/cells or their derivatives must clearly indicate on the label.
The biggest challenge, MDR mandates that all warnings relating to a device must be printed on the label.
Every active implantable device must have its own unique serial number. Other implantable devices will require a serial or lot number that leads to a data-led labeling system.
The MDR requires a Global UDI initiative similar to already implemented FDA UDI rules.

Medical Device Labeling Review

Medical Device Labeling review consists of a review of your present label in accordance with US FDA or EU MDR / EU IVDR regulation. It does not involve the development of a new label or guidance for the development of a new label. Check our pricing below. (The fees applicable for both EU & US FDA).

Class I Medical Device review : $ 650
Class Is / Im / Ir / IIa Medical Device review : $ 850
Class IIb Medical Device review : $ 950
Class IIII Medical Device Review : $ 1050
Class A IVD Device review : $ 650
Class B / C IVD Device review : $ 850
Class D IVD Device review : $ 1050

Medical Device Symbols

There are multiple languages in EU territory, which creates the necessity to use symbols. The use of symbols on the information panel / label is a substitute to written language and is detailed in annex 1 chapter III 23.1.h of MDR Regulation.

How to build a Medical Device Technical Documentation as per MDR 2017/745? We have the answer and the right team to do it for you.

Free MDR Proposal

Free IVDR Proposal

Frequently Asked Questions

Does the IFU/Label language match with country of sale?

Instruction for Use (IFU) and the label of a product typically match the language spoken in the country where the product is sold. The identified label and the IFU will be translated by an agency or individuals who are authorized for translation and arrange for the label and IFU to be printed in the required language.

Single-use Device Labelling Requirment

Single-use Device: The name and address of the legal or natural person (who should be the manufacturer of the reprocessed device) and the other relevant information referred to in above sections 5.2 and 5.2 should be indicated on the label and, where applicable, in the instructions for use of the reprocessed device as mentioned in 5.2 (o). The name and address of the manufacturer of the original single-use device should no longer appear on the label but should be mentioned in the instructions for the use of the reprocessed device.

The labelling of the device should distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition in addition to the symbol used to indicate that devices are sterile

If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system should be safe and should not impair the specified performance of the devices. Any restrictions on use applying to such combinations should be indicated on the label and/or in the instructions for use.

What are requirements for sterile packaging label?

The following particulars should appear on the sterile packaging:

An indication permitting the sterile packaging to be recognized
A declaration that the device is in a sterile condition
The method of sterilization
The name and address of the manufacturer
A description of the device
If the device is intended for clinical investigations, the words ‘exclusively for clinical investigations
If the device is custom-made, the words ‘custom-made device’
The month and year of manufacture
An unambiguous indication of the time limit for using or implanting the device is safely expressed at least in terms of year and month.
An instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.