PCN & UFI for Other Medical Devices

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:

*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 Other Medical Devices

Other medical devices, which do not fall under specific categories like cleaning or disinfection products, must still comply with EU regulations when they contain hazardous substances. To ensure that emergency responders and healthcare professionals can act quickly in case of exposure or poisoning, a Poison Centre Notification (PCN) is required. By submitting the PCN, manufacturers provide vital safety information about the chemical components in their medical devices, helping protect the health and safety of users and patients.

What is a UFI?

The Unique Formula Identifier (UFI) is a code used to identify specific formulations of chemicals within products. For medical devices, the UFI is used to provide emergency responders with detailed, product-specific information about the chemical content. This allows responders to identify the exact mixture and take appropriate action in case of an emergency.

What is a PCN?

A Poison Centre Notification (PCN) is a report that manufacturers are required to submit to the Poison Centres. It contains critical information about the hazardous properties of products, including the chemicals used in medical devices. The PCN includes hazard classifications, first aid measures, and other emergency response details. This information is essential for healthcare professionals and emergency responders to manage chemical exposure incidents effectively.

What is CLP?

The Classification, Labelling, and Packaging (CLP) Regulation sets out the criteria for classifying chemical substances and mixtures. It ensures that products, including medical devices containing hazardous substances, are clearly labelled with hazard symbols, precautionary statements, and first aid instructions. CLP provides a standardized way to communicate chemical hazards across the EU, ensuring safety and awareness at all levels.

What is the Poison Centre?

The Poison Centre is a network of national poison control centres that collect, process, and provide information on hazardous chemicals. Manufacturers of hazardous medical devices are required to register their products with the Poison Centre so that safety information can be shared with healthcare providers and emergency responders. This ensures a rapid and coordinated response in the event of chemical exposure.

Why is This Needed?

Medical devices can contain chemical substances that pose risks to users or patients if accidentally exposed to them. The submission of a PCN helps ensure that emergency responders and healthcare professionals have immediate access to critical safety information in case of exposure. This prompt access can make the difference in preventing or minimizing harm, ensuring that medical devices are used safely.

Since When is This by Law Obligatory?

Since January 1, 2021, it has been a legal requirement for manufacturers of medical devices containing hazardous chemicals to submit a Poison Centre Notification (PCN). The obligation stems from the EU CLP Regulation, which aims to improve safety standards and response procedures for hazardous products across the European Union. Compliance with this law is essential for market access and consumer protection.

FAQ

Question: Do I need to submit a PCN for my medical device?

Answer: Yes, if your medical device contains hazardous chemicals, a PCN is required. This ensures that emergency responders can access vital information about the chemical substances in your product, improving safety in the event of exposure.

Question: What information do I need to include in a PCN for my medical device?

Answer: A PCN for your medical device must include information about the hazardous substances it contains, their CLP classification, emergency response measures, and the UFI. It is crucial to ensure that the information is accurate and complies with EU regulations.

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 the removal of your product from the market. Additionally, emergency responders may lack critical information to manage exposure incidents, which can lead to severe health consequences.

Question: How can I submit a PCN for my medical device?

Answer: To submit a PCN, you will need to gather the necessary safety data, including the UFI, CLP-compliant product label, and hazard classification. Our company offers services to help you prepare your product’s notification and submit 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.