Globally, the medical device industry has always been of great importance, which has grown in the last year following the spread of the Covid-19 virus.
Placing new medical devices on the market contributes to the improvement of the health protection level, through innovative systems for the diagnosis, prevention, treatment and rehabilitation of patients.
To ensure safe and controlled access to medical devices, manufacturers will soon need to take account of the new Regulation (EU) 2017/745, effective May 26, 2021. The regulation gives greater attention to the safety and effectiveness of devices and requires manufacturers to have a higher level of accountability for production and marketing control. In this scenario medical translation plays a crucial role.
The documentation of technical devices according to Regulation EU 2017/745
Regulation 2017/745 requires medical device manufacturers to adopt a specific process for managing multilingual documentation. Each device must be accompanied by technical documentation describing the design and manufacturing aspects, as well as product validation and clinical evaluation documents. All of this information must be translated into the languages spoken in the foreign markets where the device is exported in order to ensure its safe use by medical personnel and the patient.
What are the main information requirements of the technical documentation?
- clinical condition to be diagnosed, treated and/or monitored;
- patient selection criteria, indications, contraindications and warnings;
- operating principles of the device;
- description of the accessories used in combination with the device;
- technical specifications: features, raw materials, dimensions and performance attributes of the device;
- labels, instructions for use and commercial packaging;
- EU Declaration of Conformity;
- identification of the locations where design and manufacturing activities occur.
Managing translation for medical devices
Medical translation requires strict monitoring processes concerning textual content, which must be checked multiple times before being validated. It is essential to have multilingual glossaries with up-to-date scientific terminology verified by medical specialists.
An accurate translation can only be achieved by going through each step of the validation process. One of these involves having the translation proofread by a qualified, native-speaking reviewer with medical experience. This person verifies the lexical-grammatical correctness of the translation and the consistent use of technical terminology in the medical context.
Some manufacturers of medical devices employ unskilled in-house resources to perform these delicate translations, such as marketing or sales employees with some knowledge of common languages like English and French, practically foregoing the entire validation process, with obvious repercussions on final quality, deadlines, management efficiency and total cost of the operation.
The ideal and safest solution is to rely on a professional translation agency with proven experience in medical and scientific translation services and compliant with the ISO 9001 and ISO 17100 Quality Certifications.