How does the UFI creation and PCN notification service work?
After purchasing this service, you will receive access to the secure portal. This portal contains an overview of all steps. You fill in your product details and we will get to work.
Poison Center Notification & UFI
We will provide:
- Your product’s Unique Formula Identifier (UFI)
- A Poison Centre Notification (PCN) report
- Registration of your product with the relevant national Poison Centres via ECHA.
Countries for PCN registration
You can count the number of countries in which you want to register your product. This is the number of countries you need to purchase. You will be able to select the specific countries within the portal. If you plan to expand the sales of your products to new countries at a later date, then you can always order additional PCN country registrations.
The EU has 27 countries and the EEA has 30 (EU+Lichtenstein, Norway and Iceland) In the portal you can select these countries:
| Belgium | (BE) | Spain | (ES) | Hungary | (HU) | Slovakia | (SK) |
| Bulgaria | (BG) | France | (FR) | Malta | (MT) | Finland | (FI) |
| Czechia | (CZ) | Croatia | (HR) | Netherlands | (NL) | Sweden | (SE) |
| Denmark | (DK) | Italy | (IT) | Austria | (AT) | Germany | (DE) |
| Cyprus | (CY) | Poland | (PL) | Iceland | (IS) | Estonia | (EE) |
| Latvia | (LV) | Portugal | (PT) | Liechtenstein | (LI) | Ireland | (IE) |
| Lithuania | (LT) | Romania | (RO) | Norway | (NO) | Greece | (EL) |
| Luxembourg | (LU) | Slovenia | (SI) | Switzerland* | (CH) |
*For Switzerland we can create the PCN dossier, with all the needed information to make a submission in the Swiss portal. Contact us for more information.
CLP Label Information
We offer the option to purchase a CLP compliant product label, containing all mandatory information as required by the EU CLP Regulation. This will be provided as a PDF. This is not a design, but a summery of the required information. This will enable you to integrate the necessary information into your product label design. You can also order the CLP label creation separately. Already have a label? — We can do a CLP label compliance check of your label in accordance with current CLP requirements. We will provide detailed feedback and corrections to ensure your label meets all regulatory standards.
Poison Centre Notification for Medical Devices
Medical devices, as defined in Regulation (EU) 2017/745 of the European Parliament and of the Council, must comply with EU regulations to ensure their safety and proper use in healthcare settings. For medical devices containing hazardous substances, a Poison Centre Notification (PCN) is required to provide detailed safety information in case of emergency exposure. This notification ensures that emergency responders and healthcare professionals can take appropriate actions if accidental exposure occurs, helping to prevent harm to patients and users.
What is a UFI?
The Unique Formula Identifier (UFI) is a code that is assigned to a mixture of chemicals, such as those used in medical devices that contain hazardous substances. The UFI allows emergency responders to quickly identify the specific chemical formulation of a product, aiding in the swift management of any exposure incidents. The UFI is included on the product label to provide instant access to this critical information.
What is a PCN?
A Poison Centre Notification (PCN) is a report submitted by manufacturers, containing detailed information about the hazardous properties of their product. For medical devices, the PCN includes data about chemical substances present in the product, their classification under the CLP Regulation, and the necessary first aid measures. The PCN helps emergency responders access vital safety information in case of exposure to the device’s chemicals.
What is CLP?
The Classification, Labelling, and Packaging (CLP) Regulation provides a framework for classifying hazardous substances and mixtures. It mandates that products, including medical devices with chemical substances, be clearly labelled with hazard symbols, signal words, and precautionary statements. This regulation ensures that users and emergency responders are aware of the risks and know how to handle the product safely in case of accidents.
What is the Poison Centre?
The Poison Centre is a network of national poison centres responsible for gathering, managing, and disseminating information on hazardous substances and mixtures. Manufacturers must register their hazardous products with the Poison Centre to ensure that critical safety information is readily available to healthcare professionals and emergency responders across the EU in case of poisoning or exposure.
Why is This Needed?
The PCN is essential to ensure that emergency responders have accurate and timely information about the hazardous substances in medical devices. In case of exposure to harmful chemicals, the PCN allows for faster, more effective intervention, reducing the risk of injury or death. Submitting a PCN helps protect the safety of users and patients by making emergency procedures more efficient and ensuring compliance with EU regulations.
Since When is This by Law Obligatory?
The requirement for submitting a PCN for medical devices that contain hazardous substances came into effect on January 1, 2021. Under the EU CLP Regulation (Annex VIII), manufacturers must notify the Poison Centre for all hazardous mixtures, including those used in medical devices. This regulation is part of ongoing efforts to ensure product safety and improve emergency response throughout the EU.
FAQ
Question: Do I need to submit a PCN for my medical device?
Answer: Yes, if your medical device contains hazardous chemicals, you must submit a Poison Centre Notification (PCN). This ensures that emergency responders have the necessary information to respond to accidents or exposure incidents involving the device.
Question: What information is required for a PCN submission?
Answer: The PCN submission includes detailed information about the chemical substances in the product, their classification under the CLP Regulation, emergency response measures, and a UFI. This information helps emergency responders assess the situation quickly and accurately in case of exposure.
Question: What happens if I don’t submit a PCN for my medical device?
Answer: Failure to submit a PCN can result in fines, penalties, and potentially the removal of your product from the market. Additionally, emergency responders may lack critical information to manage exposure incidents effectively, which could result in severe health consequences.
Question: How do I submit a PCN for my medical device?
Answer: To submit a PCN, you will need to provide a UFI, a CLP-compliant product label, and detailed information about the hazardous chemicals in the device. Our company can assist you in preparing the necessary documentation and submitting it to the Poison Centre for compliance.
Question: How long does it take to submit the UFI and PCN notification?
It takes us a few days’ work. As soon as you upload the documentation, we will get started right away.
Question: Am I the owner of the PCN notification?
Yes, you are the owner of the PCN notification. You retain full ownership of the data you provided. The PCN notification will be accessible in your ECHA account.
Question: Is this service for one product or more?
The service is for one product.
Question: Why do I have to pay to create a UFI?
The service we offer is not just about providing a UFI. The UFI is a component within a much more extensive process. The core service we provide is the preparation and submission of your Poison Centre Notification (PCN) to national appointed bodies through ECHA portal, which is a mandatory requirement under the EU CLP Regulation for placing hazardous mixtures on the market. Generating a UFI is simplest part. The PCN report, however, is complex. It demands detailed ingredient review—chemical classifications—formatted precisely for Poison Centre submission via ECHA.
Question: My company is not based in the EU, how can I submit a PCN?
We provide a solution for companies which are not based in the EU. You can find more information on the PCN & UFI for non-EU companies page.
Question: Can you provide Safety Data Sheets in full compliance with EU Regulation (REACH & CLP)?
Yes, we can create Safety Data Sheets (SDS)— also known as Material Safety Data Sheets (MSDS)— tailored to your product and compliant with the latest EU regulations. Whether you are manufacturing chemical mixtures, importing products into the EU, or distributing under a private label, a compliant SDS is legally required and essential for safe use throughout the supply chain. You will find more on the Safety Data Sheet (MSDS/SDS) Creation Service page.
