How They Work in Tandem
May 2020 marked the end of the transition from the European Union’s Medical Device Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) to the new Medical Device Regulation 2017/745 (MDR). Although the MDR overlaps in many respects with its predecessors, it differs in two important ways:
- The MDR expands the definition of medical device to include things like non-prescription colour contact lenses.
- The MDR requires increased transparency by making information on devices and studies public. To this end, the EU created the new European Database for Medical Devices—EUDAMED—which will store the data and make it available to the public.
In other words, the number of devices included in the directive has greatly expanded, and more documentation is required for each device a company wishes to bring to market in any member countries of the EU.
Medical Device Documentation
Language is increasingly being regarded as an integral part of the product and is consequently subject to equally strict regulations. These changes, alongside many others, call for more documentation. According to the MDR, documentation must be provided in the European language(s) that the member state the device is being sold in requests.
As any company who develops, manufacturers, and sells medical devices knows, accurate documentation is critical. Documentation that contains errors can lead to difficulties with product approval, inappropriate use, and possible injury.
Therefore, each language the medical device documentation is provided in must be accurately translated. Medicine is growing with enormous speed, spurred on by trends such as precision medicine, increased outpatient care, and more care in the home. Accompanying this growth is an increase in documentation, and it must be accurate, regardless the language.
How These Changes Benefit the Market
Although these new policies mean more hurdles for manufacturers to overcome, they will bring with them several improvements. As the Factsheet for Manufacturers of Medical Devices states, “The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers.”
Because these new policies mean more documentation and reports, most likely in multiple languages, working with a translation services provider who knows the industry and regulations and can translate the medical documentation quickly and efficiently will help reduce time to market.
t’works Is Your Partner
As certified language service providers who have been translating medical technology texts for over 70 years, we at t’works understand the MDR and related regulations. We are familiar with the requirements for technical documentation, which will be regulated in much greater detail in the future, as well as the new requirements for medical device labelling. We feel perfectly equipped to assist manufacturers not only in terms of language, content, and editing but also in terms of procedures for implementing the new MDR. We would be happy to advise you individually and discuss concrete steps of the procedure for your specific products together.