A Guide to MDR Translation Requirements
The European medical device regulation, or EU MDR, is a set of regulations that govern the production and distribution of medical devices across Europe.
Introduced to improve the safety of end users and quality of products, the regulations aim to achieve this, in part, by enabling EU member states to determine their own language requirements pertaining to the information manufacturers must provide with a device.
At Andiamo, we’ve been helping clients to prepare for and meet MDR translation requirements since the regulations were first introduced in May 2017, and took effect on May 25th 2021. As MDR transition provisions differ depending on device classification, if your organisation isn’t yet ready, it’s time to prepare to ensure your compliance, and we hope this blog, or our ISO-accredited medical device translation services can help.
MDR Translation Requirements & What They Mean
Article 10, section 11, of the MDR states:
“Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient”.
What does this mean and what are the MDR translation requirements this regulation presents?
- The language requirements apply to your: IFUs, product labels, sales packaging, technical files, clinical evaluations and reports, Declaration of Conformity documentation, official statements, field safety notices, and SSCPs. (Outlined in Section 23 of Annex)
- You may need to translate content in up to 24 EU languages, depending on the language requirements of the EU countries in which you sell your device.
- MDR translation requirements may vary across each EU member state, based on the state’s policy around device classification, intended use (whether it’s going to be used by individuals at home or professionals in a medical/healthcare setting), and content type (with safety information falling under stricter regulatory scrutiny).
- Translation may become more of a continual process for your organisation, as the MDR website states that translations must be kept up-to-date. We take a consultative and collaborative approach to MDR translation. We don’t just translate – we become an extension of your regulatory and quality teams.
How to Approach MDR Language Requirements
When you consider that the international sale of your medical devices hangs on compliance with these MDR translation requirements, and the potential scale of the translation work required to comply with the language requirements of just a single EU country, working with a trusted translation agency is essential.
EU MDR language requirements are focused on providing clear and accurate information with each device, to ensure user safety and device ease of use. Therefore, it’s important to find an agency that:
- Works with translators who possess not only the required linguistic skills, but the medical device translation experience, to ensure that the correct sector-specific terminology is used and accurately communicated.
- Works with a range of translators with medical sector specialisms, as MDR-compliant translations should be revised by another specialist translator to ensure they are correct and accurate.
- Can provide certified translations (a letter of authenticity), which your organisation’s compliance department may require.
The Benefits of Professional MDR Translation Support
Beyond facilitating the international sales of your medical devices, and safeguarding both your brand and your end users, working with a trusted professional agency to ensure your translations meet MDR translation requirements has a number of additional benefits.
- Professional LSPs offer the peace of mind that your translations are created by competent, specialist medical translators who produce quality, accurate work you can trust. Unlike AI models.
- Working with a critical supplier, specialised in the medical and life sciences sector, can provide the end-to-end, fully managed support that your organisation needs, and that would be hard to source and manage if you were to take a freelance approach. For example, providing both a high-quality translation and DTP service, to present your MDR-compliant translations in the optimum way.
- A trusted LSP, who holds the necessary ISO standards and is externally audited by a UKAS auditing body, can help to ensure your compliance with MDR language requirements and streamline your approval process.
- LSPs can utilise CAT solutions, including translation memory (TM), to reduce costs and turnaround times, whilst supporting the consistency of translations. These tools are especially useful when translating updates made to your existing, prior-translated content. We don’t recommend using machine translation (MT) solutions for medical translations, unless the engine has been trained specifically using accurate medical translations.
Why Andiamo?
Andiamo! hold ISO 13485:2016 and ISO 17100:2015 certifications, demonstrating our commitment to the medical devices sector, and the quality of the translations we provide to our many clients in this sector.
We offer you the peace of mind that sector-specialised, skilled, experienced and assessed linguists, who are native speakers of the EU languages you need to translate for, are working to support your international growth.
We are regularly externally assessed to maintain our ISO standards, can provide a letter of authenticity with translations on request, and offer a Gold Service in which we produce ISO 17100:2015-compliant translations.
The sales of your products, and the safety of its users, are in safe hands.
If we can help your organisation to navigate MDR translation requirements, contact our team today.
