€0.00 – €69.00
Field Safety Notice template for medical devices and in vitro medical devices, intended for healthcare professionals, available in a number of EU languages
Explore our Field Safety Notice template available in English (free download), French, German, Italian, and Spanish. These language versions of the Field Safety Notice template are an essential tool created to assist manufacturers of medical devices and in vitro diagnostic medical devices (IVDs) in meeting the specific notification requirements set forth by Medical Devices Regulation (MDR) 2017/745/EU and In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746/EU.
Medical device manufacturers are responsible for promptly reporting any serious incidents involving their products within the EU market and any related field safety corrective action (FSCA) to a competent authority. To ensure regulatory compliance under Article 89 of the MDR and Article 84 of the IVDR, manufacturers must also communicate the FSCAs to the device users through a Field Safety Notice (FSN). These FSNs must be translated into the official union language or languages determined by the Member State in which the FSCA is being taken.
While Article 89(8) of the EU MDR and Article 84(8) of the EU IVDR outline the fundamental components that must be included in the FSN, they do not prescribe the exact content of the FSN. Nonetheless, both Articles emphasize the necessity for FSN content consistency across all EU Member States, except when duly justified by the situation of the individual Member State. To facilitate this, the European Commission (EC) has agreed a common FSN form for the communication of FSCAs within the EU, exclusively applicable to FSNs intended for healthcare professionals. This standardised EU FSN template, as stated in the guidance document published on the EC website, is not obligatory but is strongly recommended in the interest of consistency across the 27 EU Member States.
The official EU FSN template is available in English only. At the request of our clients, we have prepared professional translations of this official FSN template in a number of languages. These language versions of the FSN template stand as a valuable resource for manufacturers of medical devices and their representatives who wish to streamline their vigilance reporting process.
Download our FSN templates today and embrace regulatory compliance with confidence.
English, French, German, Italian, Spanish
Our EU MDR/IVDR Field Safety Notice Template in EU languages has been purchased by a number of medtech companies to support their vigilance reporting processes. Here is what they say:
‘These FSN template translations are incredibly useful for our regulatory team. We can keep them on file and use them as needed. They save us both time and money.’
RA Manager, Italian medtech company
‘We were delighted to find this Field Safety Notice template available in various languages. It’s a genuine time and cost-saver.’
Quality Assurance Director, German medtech company
‘Your professionally translated FSN templates have saved us valuable time and effort. Preparation is crucial.’
RA Coordinator, US medtech company
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- Debit/Credit Card: Choose this option for immediate access. Upon payment, you will receive a confirmation email with the download link. Within 48 hours, you will also receive a VAT invoice for your order.
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After making the payment, you will receive a confirmation email with the download link. To expedite the process, you can email us a payment confirmation as evidence of your payment.
Please note that the prices displayed do not include UK VAT. Orders from the UK will have a 20% VAT charge added. However, orders from the EU and the rest of the world are subject to a 0% VAT charge.
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- Are these translations reliable?
Yes. All translations have been prepared by our linguists who ensured MDR terminology was used throughout.
- Are there any subscription fees for this product?
No. You only need to make a one-time payment. Your organisation can use the product without any recurring charges.
- Are there any usage restrictions?
Your organisation is permitted to use this product for internal purposes. However, if you are a consultancy working with other organisations, your clients should purchase their individual copies. Please note that this product is copyrighted and must not be distributed outside of your organisation or shared publicly.
- What is the file format?
Upon purchase, you will receive a download link for the product in the MS Word format. The product can be easily opened and fully edited with any text editing application and does not require activation or a password.
- Who can we contact for technical support?
For technical support, please contact us at: firstname.lastname@example.org. We are here to assist.