Our health systems are under huge pressure due to ageing populations and chronic diseases, not to mention the Covid-19 pandemic. MedTech provides healthcare professionals with devices and tools to restore our health when we are unwell – and naturally, correct translation and localisation of information is crucial.
To meet the current healthcare challenges, the European Alliance for Value in Health has been created to help advance value-based, sustainable and people-centred health systems. The alliance consists of a number of associations representing patients, hospitals, health authorities and life-science industries including MedTech Europe, the European trade association for the medical technology industry.
According to MedTech Europe, medical technology encompasses products, services or solutions used to save and improve people’s lives. This advanced technology is used at every stage of the patient journey: prevention, diagnosis, monitoring, treatment, and care. If we are unwell, medical technology can accelerate our recovery and keep us healthy.
There are three main types of medtech products: medical devices such as X-ray machines and pacemakers; In Vitro Diagnostics (IVDs), such as pregnancy tests and Covid-19 diagnostic tests, which provide information based on a sample; and digital health solutions including tools and services to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
Strict requirements on MedTech localisation
MedTech is crucial, and so is localisation of its content, and the industry is known for its rigorous translation and linguistic validation processes. In October, Slator released the 2020 Medtech Translation and Localization Report, which describes the complex landscape of translation and localisation services for medical technology, a market valued at USD 0.8bn in 2020. The report gives an overview of the industry and emerging transformational technologies such as interconnected medical devices, software as a medical device (SaMD), and telehealth. It also examines the regulatory context of the industry, including a new regulatory framework in Europe.
Slator recently hosted the virtual conference SlatorCon Remote December 2020, which included a MedTech panel with representatives from Varian Medical Systems and Medtronic. They discussed topics such as workflow within the regulatory context and tools used in MedTech localisation. Machine translation (MT) was also on the agenda, and Varian’s localisation manager Aurélie Baechelen reflected: “There’s great interest, at my company at least. The big question is how do you fit MT into the regulatory framework. For example, how do you document the process? How does post-editing fit into the certification for medical devices?”
As the potential impact of incorrect translations around a patient’s health and well-being could be fatal, quality is top priority for both MedTech and its translation partners. It falls on language service providers to stay on top of new regulatory contexts in Europe. The EU Medical Device Regulation (EU MDR) became mandatory in all EU member states in May 2020, with the requirement that medical device content be translated into the official languages of the member states where it will be marketed. Moreover, the EU In Vitro Diagnostics Regulation (EU IVDR), a related regulation specific to diagnostic tests and screenings, will become mandatory in 2022.