Medical Devices – Translation Requirements. The medical device regulations are the rules that companies must follow in order to sell medical products in the European Union. All these regulations are to ensure the quality of the products and also ensure that the translation requirements are met. As of 2021, they implemented a rule that says that manufacturers who do not comply with the new regulation would be forced to withdraw their products from all EU countries. There has been a lot of confusion about how to comply with these new regulations, therefore in this post some of the key articles of the regulation are explained and recommendations are given to minimize the impact of these regulations. Some of the key highlights of the articles are:
- It is essential that any product information and documentation is provided in an official EU language. In addition, the instructions for use and packaging must be included in the language of the country where the device is sold.
- If a product is going to be private labeled or repackaged all restrictions apply, this means that an appropriate quality management system must be in place to ensure that all business units follow translation requirements.
- Healthcare professionals and patients must be provided with information that identifies the product, the manufacturer, the shelf life of the product and any extra steps or instructions, this information must be provided in the language of the country in which the product was sold. .
- The declaration of conformity must be translated into an official EU language (English is one of the official EU languages).
- All information about the clinical performance and safety of the device must be clearly written and made public through Eudamed.
- The EU establishes a system that captures clinical investigations, the information supplied to the system must be presented in the language of the country involved in the investigation.
Manufacturers must take steps to mitigate risks as failure to comply with these new regulations could lead to company products being withdrawn from the market. Therefore, for the impact of these requirements, it is first recommended to have a rapid communication plan for corrective actions in multiple languages and to establish response times with suppliers in the event of an urgent situation. It is also recommended that contracted providers have a quality control platform, with adequate documentation and corrective action procedures. And it must be ensured that providers comply with translation standard operating procedures.
The translation provider should be required to have a full audit trail for each project undertaken. This document must include an audit trail of the translators and editors involved in the project, the names of the documents, the relevant dates of the project, and an affidavit of accuracy. It is also important to ensure that the translation provider maintains the reading level as written by the manufacturer. This is essential since the articles of the regulation reinforced that each document must be written to maximize the level of understanding on the part of the foreseen.
The translation should be as transparent as possible, if you are paying for the service you should have a full understanding of the steps and tools that are being used to provide it, including the quality control steps that follow. It is important to have a provider that has transparent prices; however, the most important thing is that they do a high-quality job and meet all the requirements.
