Before a new medical device is placed on the market and authorized for use, it must undergo a conformity assessment procedure. Its aim is to verify whether the product meets all the applicable core requirements. Labelling and instructions for use are among the elements to be verified. The language, which must be adapted to the target recipient, plays a crucial role. The assistance of a professional translator may prove invaluable to help the product sail through the conformity assessment process.

Conformity assessment procedure – who performs it?

The conformity assessment procedure for a medical device may be conducted in two different ways, depending on the class of the medical device, which determines the risk associated with its use.

  • Risk class I medical devices (non-sterile and without a measurement function) – the manufacturer may independently conduct the conformity assessment procedure, issue the declaration and mark their product with the CE mark.
  • Medical devices in higher risk classes – the manufacturer must not conduct the conformity assessment on their own and a notified body (e.g. Polskie Centrum Badań i Certyfikacji S. A. (1434)) must be involved in the process.

Requirements for labelling and instructions for use

The entity placing a medical device on the Polish market is required to label it in the Polish language. The instructions for use attached to the product, as well as its label, should also be in Polish. Please note that while it is true that devices supplied to healthcare providers may come with labels or instructions for use in English (or a different language), this is only allowed upon the recipient’s written consent and does not apply to any information intended for patients. Details intended for patients must be written in Polish or have the form of harmonized symbols or recognizable codes.

Translation of medical device documentation

Placing a new medical device on the market requires a range of diverse formalities to be cleared, including the translation of particular documents into the languages of the recipients. One of the formal requirements which must be met early on, when a medical device is notified, is the submission of a short description of the device and its intended use both in Polish and in English. Usually, local regulatory authorities must receive the documentation in a particular language.

The documents must be translated accurately so that their content is accurate. There is no room for error, considering that every medical device is intended for use in healthcare. This is why a professional translator’s support may prove invaluable when translating particular elements of the dossier.

KONTEKST – assisting you with the translation of labelling and instructions for use into other languages

Are you a medical device manufacturer and need to translate documents for a product which is about to hit the market? KONTEKST translation agency is here for you. We will be delighted to help you translate instructions for use, user guides, approvals and conformity certificates, letters or authorisation and much more.

Entrust us with the translation of your medical device documentation to be sure that it will be handled by a professional with the right education and experience, as well as expert knowledge of industry-specific terminology. We always match the translation project to the right translator and the final document is verified by a specialist with a medical background. This makes the final product reliable and guarantees short turnaround times. Choose our services to save time and make sure that you meet all the required document submission deadlines, so that your product can be placed on the market as soon as possible.

Our certified translations are issued with a qualified electronic signature. To learn more, call us at: +48 22 548 07 00 or send an email to: kontekst@kontekst.pl.