If you’re a medical device manufacturer in the European Union, you likely have more questions than answers when it comes to complying with the new MDR and IVDR regulations set to roll out in 2020.
As you assess your product pipeline and existing portfolio to identify change requirements, your questions likely include:
- Is your device subject to re-classification?
- Will re-labeling for existing devices be required for UDI compliance?
- Will you need to generate clinical performance data for the technical dossier or post-marketing surveillance?
- How should you handle content requirements regarding public accessibility on EUDAMED?
For the sake of clarity…and the user
With all the changes being implemented for medical devices and IVDs in the EU, you probably haven’t thought about the implications of language and the vital role of translations yet. In the old days, the process went like this: a manufacturer developed a device and obtained a CE marking, then established and translated labeling and Instructions for Use (IFUs) before launching the product.
Today, IFUs are part of the device’s technical dossier and will need to be submitted for review by Notified Bodies along with the package labeling. Approved IFU content will also need to be available on the manufacturer’s website and, where applicable, the IFU should link to a summary of safety and clinical performance which must be written in a language understandable to the user and uploaded to EUDAMED. These new requirements increase a patient’s access to safety and performance data about the device.
From a usability perspective, IFUs are critical—medical devices only work as intended if they are used correctly. The EU is requiring precise language in all markets to ensure the correct and safe use of devices once they are in the hands of patients or operators. The new EU regulations underscore the importance of language clarity, especially on content intended for the end user. That focus is apparent in the emphasis given to language quality in the legal text examples below:
- Labeling particulars must be “clearly comprehensible to the intended user”
- Information supplied with devices for self-testing or near-patient testing must be “easily understandable to the user”
- Instructions for use “shall be written in terms readily understood by the intended user, and, where appropriate, supplemented with drawings and diagrams”
- A summary of safety and performance must be submitted for class III and implantable devices in a language “easily understandable to the intended user”
Language has become a core activity to obtain regulatory compliance and to ensure the safe use of medical devices in the EU. Additionally, language is a priority of the European Commission to enable an effective trade across the European Union. In the EU, multilingualism is a core policy, and citizens have the right to communicate with EU institutions in any of the EU’s 24 official languages. All content intended for users and patients for medical devices traded in the EU must thus be available in the local languages of all Member States where the products are distributed.
Scaling up for regulatory success in 2020 and beyond
A successful regulatory strategy for meeting the new compliance requirements includes a content translation and review process that delivers clarity and accuracy across all languages from the start. Guidance from a language service partner with a strong track record in medical devices can be instrumental in avoiding any pitfalls and supporting the swift registration and use of your products. The potential risk of a false positive or false negative diagnosis—or field safety incidents caused by poorly translated instructions—is not a scenario you wish to confront.
At Lionbridge, we are fully prepared to be the best possible compliance partner for our MedTech customers. We invite you to reach out and discuss how our team can help achieve linguistic compliance and accurate content in all 24 official EU languages under the new MDR and IVDR. We bring a solid track record in medical devices as well as in clinical translations, and we can help you tackle DTP challenges under the new UDI labeling requirements.
Let us help you configure a path to global content clarity under the new regulations. Please contact us to start a conversation.