Label & IFU Consulting

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Label & IFU
Consulting

Background

The manufacturer is required to provide the user or patient with appropriate information such that the product can be used both safely and effectively throughout its lifetime. The required information on labels and instructions for use is indicated in Annex I of both the EU MDR and IVDR. Depending on your product’s intended purpose, there may be specific requirements which need to be met. As an example, if your device is packaged within sterile packaging, the sterile barrier will need to be indicated as such.

Proper labelling goes hand in hand with the appropriate use of international standards on symbols. Not only is the use of symbols required in the Regulations, it is also a universal system for providing information to the end user. Thus, getting your symbols right is considered a key safety feature.

Medical device software developers, beware! You will not be let off the hook so easily. You will still need to meet these requirements which can be achieved by indicating the required information on the ‘About’ or ‘Loading’ page of your software.

We frequently get asked whether manufacturers can begin replacing physical instructions provided with their products with an e-IFU. However, to do so requires a good understanding of the requirements and criteria set out in Regulation (EU) No 207/2012.

We also cannot stress enough the importance of getting the CE mark done correctly in the appropriate proportions. Go to this link to use the correct CE mark.

The MDR introduces new requirements, such as the indication that a product is a medical device, indicating the sterile barrier, and the UDI. These all have corresponding symbols to indicate this information!

Services

Labelling mistakes can be very costly and we understand that all these requirements can sometimes be difficult to keep up with. Let us have a look at your labels or instructions for use and we will let you know what’s missing and where you can improve.

You may also contract us to develop a regulatory plan for meeting your labelling and IFU requirements. We will provide you with a document detailing exactly what information should be placed on your device / packaging / IFU and which international symbols should be indicated.

What you get with Specculo

We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.

Experience

As your regulatory consultant, you get our full attention throughout the project.

Expertise

You can expect high quality, state of the art technical documentation.​

Fast lead times

We give you our time and take you through the created documentation, and how to maintain it.​

Simplify your compliance workflow.