In March 2020, as the COVID-19 crisis spread, the EU Commission recommended postponing the introduction of the MDR by a year. Although that certainly relieved the pressure for many manufacturers, the question is: what to do with the extra time? Use it to prepare for when the MDR is introduced, of course! The MDR imposes stricter requirements on medical products and on how they are translated and localized. Translations must be provided in up to 24 languages and be clear and precise. Selecting an ISO 13485 certified language service provider is the best way for manufacturers to ensure that their translations are sufficiently high-quality for their devices to be approved for use in the EU.
In May 2021 the new European Union Medical Device Regulation (2017/745), MDR for short, will take full effect. It increases the requirements manufacturers must meet before their medical devices can be launched onto the EU market – both in terms of the products themselves and their documentation. And the new MDR broadens the definition of “medical device”, meaning that many more devices, such as prescription coloured lenses, are now covered by its remit.
Stricter requirements for manufacturers of medical devices
The MDR replaces the old Medical Devices Directive 93/42/EEC and the Directive 90/385/EEC on active implantable medical devices. Its stricter requirements aim to increase patient safety, improve transparency and ensure fair market access. One consequence is that medical device manufacturers must demonstrate that their devices are MDR-compliant through a conformity assessment, which varies depending on the risk class of the device. Every medical device must have a Unique Device Identifier (UDI), and the MDR also requires manufacturers to produce additional reports and comprehensive documentation – if language issues (i.e. translations) hadn’t already come into play, they certainly do here.
How the MDR affects translations
Translations have always been extremely important in the medical device industry, as without them medical professionals around the world wouldn’t be able to use devices correctly. Misunderstood instructions can prove very dangerous for the device, the user and/or the patient. The MDR is a further step towards recognizing that the documentation is an integral part of any medical device, and it imposes strict regulations in terms of the languages required. Specifically, it states that “Manufacturers shall ensure that the device is accompanied by the information [...] in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.”
There are 24 official languages across the EU in total, so depending on where manufacturers plan to market their devices, they may need to translate the required documentation into up to 24 languages. And the requirements for the translations are just as high as they are for the original texts: instructions, markings, safety information etc. must be clear and precise to ensure that the devices can be used safely by patients and medical professionals.
The certainty of the right certifications
Medical device manufacturers may well need to work with a translation agency in order to produce high-quality translations of their documentation in the languages they need. When choosing who to work with, they should of course make sure that the agency translates into all the relevant languages and specializes in medical translations. But just as important is ISO certification, and the right ISO certification in particular.
In addition to the ISO 9001 standard, which defines the requirements for quality management systems across different sectors, there is the ISO 17100 standard for the translation sector. This specifies the requirements for all aspects of the translation process, which as a whole enable language service providers to produce high-quality translations. These include:
- the procedures and criteria used to select translators,
- the translation agency’s in-house processes when preparing a job for translation,
- the translation process itself,
- and the “post-production stage”, i.e. what happens once the translator/reviewer has completed their work.
And medical device manufacturers should watch out for language service providers who say they “work in accordance with ISO” – they may meet its requirements, or at least say they do, but if they are not actually “ISO certified” then they have not been audited and certified by an objective external body.
How medical device manufacturers benefit from an ISO 13485 certified translation agency
ISO 13485 is extremely important in the medical sector. It provides an international standard for demonstrating effective quality management systems for medical device manufacturers, and its requirements are even more stringent than those of other standards. ISO 13485 applies to all businesses involved in placing devices subject to EU directives and regulations on the market, including language service providers.
It boils down to this: if a translation agency is ISO 13485 certified, medical device manufacturers can rest assured that the agency has clearly defined procedures in place and has implemented a quality and risk management system. An independent auditor has confirmed that the agency meets the relevant requirements and follows a sequence of procedures to ensure high-quality translation services. Another advantage for medical device manufacturers is that they do not need to conduct a supplier audit if the translation agency is ISO 13485 certified, as this external certification has already proved that the agency has reliable procedures in place.
ISO 13485 certification tells medical device manufacturers that the translation agency is familiar with the medical sector and its particular challenges and is aware of the risks with regard to patient safety. After all, clear and accurate translations aren’t just important for MDR-compliant CE marking: they also make medical devices safer to use and help manufacturers reach new markets and customers.
More information about the MDR is available from:
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