Medical Restrictions & Regulations affecting Translations
Medical translation is arguably one of the most important areas of translation there is, in terms of ensuring the availability of clear, accurate information across all languages. No other field of translation has so much at stake or as many medical restrictions or medical regulations.In the EU in particular, the task is both significant and complex. This is due to the nature of the EU as a closely tied network of regions with over 24 official and working languages, 28 member states, 9 outer regions, as well as 21 overseas territories. Moreover, medical research and pharmaceutical and medical device production are ongoing, with medical guidelines and best practices continuously being adapted to follow the new data being generated every day (in all parts of the world). It’s easy to see then, why only the absolute highest standard is acceptable in medical translation.
Why Have Regulations?
The need for precise, accurate translation is so vital that medical translators are required to be both highly skilled in translation, but also have wide-ranging, in-depth knowledge of medicine. As we have all seen at first hand, no other discipline has quite so unique and vast a set of terminology. Encompassing technology, chemistry and biology, coupled with the many differing abbreviations used within medicine, many obstacles need to be surmounted to produce accurate medical translations.
In such a complex mire as this, one of the most effective ways to ensure consistency across all translations is through the adoption of detailed, comprehensive regulations. In certain cases, as when translation concerns medical device production, multiple regulations need to be considered at the same time.
Medical Device Regulations and What They Mean
Regulations are essentially the rules manufacturers need to operate by in order to comply with the standards for producing medical devices in the EU. They are not merely guidelines, with significant penalties levied for non compliance. With criminal prosecution, seizures and loss of insurance facing manufacturers, the regulations are strictly followed throughout the industry.
As of 5 April 2017; Regulation (EU) 2017/745 governing medical devices and Regulation (EU) 2017/746 concerning in-vitro medical devices were adopted, and entered into force on 25 May 2017. A transitional period of 3 years and 5 years was provided respectively before penalties will be applied. Both of these new regulations promise to ensure a ‘robust EU legislative framework’ for the protection of the public based on increased patient safety.
Together with direct EU regulations, there are also ISO standards that cover both translation providers and medical device manufacturers with broader guidelines such as ISO 9001:2015. Whilst not directly referring to either sector, this general guideline provides a basis for good quality control and assurance measures and can be followed by both industries. More specifically, ISO 13485:2016 is directly concerned with the actual environment of medical device manufacturing and details the standards required to ensure safety and compliance across the board in this industry. At the same time, IEC 62304 is a regulation focused on the development and maintenance of medical device software itself, together with components and production tools.
As for translation companies and translators, we can turn to EN 15038 for standardized guidelines as to what constitutes good quality management. These standards were produced through a collaboration between the European Committee for Standardization (CEN) and the European Union of Associations of Translation Companies (EUATC).
Many translation providers also endeavor to adhere to the ISO 17100 standards, incorporating additional steps in quality assurance and conducting further checks to ensure excellence in translations through control inspections, as well as rigorous recruitment and job allocation guidelines.
A Critical Crossover
These heavy restrictions and regulations governing both the medical and translation fields create a highly specialized niche for the production of medical translations. The best medical translators thus need to be especially knowledgeable in the medical field as well as proficient in technical terminologies, but all translations also need to ensure adherence to a complex system of guidelines that covers both industries. Bearing this in mind, additional quality control measures, including but not limited to back translation and reconciliation, may be employed to make absolutely sure of legal compliance, as well as ensuring patient safety.
Needless to say, the field of medical translations is perhaps not for the faint of heart, nor for those lacking in rigour. This means that only the very best translation service providers are destined to succeed.