Is sworn translation required under the MDR (Medical Device Regulation)?

Although relatively uncommon, clients occasionally ask us to provide sworn translations of their instructions for use or labels. The request usually stems from a recommendation made by their auditor or a consultant.

The logic behind this is clear. When manufacturers need to demonstrate the accuracy of their translations, having them certified by an authorised professional may seem like a reliable safeguard. For an international quality and regulatory affairs team, it may also seem like a simple solution that can be applied across all markets.

However, the MDR does not require sworn translations of IFUs or labelling, and, as we will see, this may be because sworn translation itself isn't recommended. Furthermore, the concepts of sworn, official and certified translation do not have exactly the same meaning across all countries.

MDR requirements for translations

First, let’s briefly review the requirements set out in Regulation (EU) 2017/745 on medical devices. It establishes a common European framework, but leaves certain language-related decisions to the Member States. Article 10(11) requires the information accompanying the device to be provided in the languages specified by the country where it is placed on the market.

Annex I, section 23.1, requires instructions that the intended user can understand. Annex II, in turn, includes labels and IFUs in the languages of the intended markets as part of the technical documentation. None of these provisions requires a sworn translation.

Article 16(3) specifically addresses the accuracy and currency of translations through quality management system procedures. Its scope is specific: certain activities carried out by importers and distributors. It should not be interpreted as an obligation that applies uniformly to every translation assignment commissioned by a manufacturer.

For a QARA team, the practical implication is that meeting language requirements and controlling translation quality are related but different responsibilities. Having a version in the required language does not, in itself, demonstrate that its content is accurate.

Sworn, official and certified translation: terms that vary by country

In international projects, it is common to receive requests for sworn translations, certified translations or official translations. Before quoting or incorporating these terms into a procedure, it is worth clarifying what they mean to the person making the request.

In some countries, certain professionals are authorised to certify translations for official purposes. In others, the process involves taking an oath to certify a particular translation. Some countries also rely on a written statement from the translator, without requiring an official appointment equivalent to that of a sworn translator in Spain or Germany.

For example, the Spanish Ministry of Foreign Affairs explains that authorised professionals certify the faithfulness and accuracy of translations through their signature and official stamp. In Italy, the Court of Rome describes asseverazione: the translator assumes responsibility for the translation by signing a sworn declaration. They are distinct mechanisms, although both address the need for formal validation.

This is why a global specification that simply states that ‘all translations must be certified’ can lead to different interpretations among subsidiaries, distributors and suppliers. It is better to identify the document, its intended recipient and the specific type of certification required.

Why sworn translation cannot replace medical specialisation

A sworn translation does involve a formal declaration regarding the faithfulness of the text. The problem arises when this formality is taken as sufficient evidence of medical expertise, independent revision or document control.

A sworn translator can be an excellent medical device specialist. Both skill sets can complement each other. However, their authorisation alone does not demonstrate experience in molecular diagnostics, orthopaedic surgery or instrument reprocessing.

Most sworn translators tend to specialise in legal documents, as these are generally the types of documents submitted to public authorities. In other words, if we opted for this approach, finding translators with expertise in the medical field who are also officially authorised to provide sworn translations would be a major challenge.

When official translations may indeed be required in European markets

A manufacturer may need official translations for certain procedures, even if they are not required for distributing its IFUs. The most common examples involve judicial, administrative, corporate or public procurement documentation.

Germany, France, Italy and Spain illustrate the differences between national systems. The following examples describe the formalities required for specific procedures; they do not constitute general requirements for translating medical device documentation.

For QARA teams, the key distinction lies in how the document will be used. A declaration of conformity included in the product documentation and the same declaration submitted as part of a tender may be subject to different formalities.

Outside Europe: medical device registration may require official translations

When expanding into new markets, translation formalities should be reviewed as part of the registration strategy. Some countries do set explicit requirements for official translations of documentation submitted to their health authorities.

Turkey offers a clear example. The TİTCK guidance on medical device registration in the ÜTS system requires certain documents issued in another language, such as certificates, to be accompanied by a Turkish translation prepared by a sworn translator (yeminli tercüman). By contrast, for instructions for use, the same guidance considers a Turkish translation provided by the company itself to be sufficient. The required formality therefore depends on the type of document, not just the market.

Brazil takes a different approach. Under ANVISA RDC No. 751/2022, certain documents relating to imported products, including the manufacturer’s declaration authorising the applicant to represent it, may be submitted in Portuguese, English or Spanish. A tradução juramentada is required only when the documents are provided in another language. It would not be correct to assume that every foreign document requires an official translation in Brazil, although labels and IFUs must be provided in Portuguese.

These examples highlight the importance of maintaining a requirements matrix for each market and document type. Before commissioning a translation, the local team or regulatory representative should confirm the accepted language, the translator’s authorisation and any submission formalities.

Conclusion

The MDR does not require sworn translations of IFUs or labelling. It requires information in the language specified by each country. This information must be understandable and accurate for the intended user.

Making sworn translation mandatory for all product documentation could actually be counterproductive. It restricts the choice of translators to those who are officially authorised, few of whom have specialist medical expertise, while making every update more expensive and time-consuming.

Sworn or official translation has its place in specific procedures, such as litigation, public tenders or registrations outside the EU, and these requirements should be identified for each document rather than applied by default.

At AbroadLink, we work as a medical translation company, with certified workflows in accordance with ISO 13485 and ISO 17100 and translators specialising in medical devices. If your QARA team needs to determine which documents call for specialist translation and which require an official translation, we can help you establish the right process for each market.