It might have been postponed, but it’s still happening: the new Medical Device Regulation (MDR) will soon enter into force in the EU. In light of the major challenges facing manufacturers of pharmaceuticals and medical devices in particular, as well as other stakeholders in the healthcare sector as a result of the COVID-19 crisis, the EU Commission decided to extend the deadline.
On 26 May 2021, the new Medical Device Regulation will enter into force throughout the EU, replacing the current Council Directive 93/42/EEC concerning medical devices and Council Directive 90/385/EEC on active implantable medical devices.
For the manufacturers, retailers and importers responsible for distributing medical devices on the European market, this means that there is still time – into the spring of 2021 – to ensure that all of their product-accompanying text materials comply with the provisions of the new regulation. For example, the regulation stipulates that this informational content must be written in language that is easy for laypersons (i.e. those without medical training) to understand. And the information must also be available in every language that is required. If companies fail to comply with the requirements of the new MDR, they will face a Europe-wide ban on the sale of their respective products. That’s why it’s critically important for companies in the medical and pharmaceutical sectors to act fast over the remaining months and adapt all of their informational content to comply with the new rules!
tolingo is a translation agency that offers you an all-round service for translating content for your medical devices! Thanks to our extensive pool of highly qualified specialist translators, we can implement translation projects in over 220 language combinations – no matter the timing and in impeccable quality.
As a translation agency that’s certified in accordance with ISO 17100 (the quality standard for translation services) and ISO 9001 (systematic quality management), we can help you generateall the informational content you need for your medical devices in the respective language before the new regulation come into force.
The only way to rule out any potential restrictions on distribution in the important markets for medical devices and pharmaceuticals in the European Economic Area is to have all content and information, as well as data and required training materials, relating to the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) – which will come into force in May of 2022 – available as translations in all the necessary languages.
Whether you need translations of instructions for use, informational brochures or texts for apps relating to your medical devices – as a trustworthy and experienced partner to the medical and pharmaceutical industry, tolingo supports you by providing texts of all kinds!
The Medical Device Regulation (MDR) is an EU-wide corpus of requirements governing medical devices. This new regulation was adopted by the European Commission back in 2017; initially, a transition period of three years was agreed for medical devices that have already been approved. In other words, a deadline of 26 May 2020 was set in order to give manufacturers enough time to be able to fulfil the new MDR requirements. But due to the global crisis resulting from the COVID-19 pandemic, the deadline was extended by one year to 26 May 2021, when the new regulation will go into effect. The German Act on Medical Devices (MPG) and the CE seal have been adapted to include the new additions found in the MPR.
The MDR imposes a variety of additional requirements on manufacturers with the goal of ensuring the safe application of certain medical aids, implantable prostheses, instruments and the like. To date, this sub-area within the field of medical care has been somewhat less strictly regulated by the German Act on Medical Devices (MPG) than (for example) the regulations governing medicinal products in the pharmaceutical industry. However, ensuring a high level of safety is equally essential for medical devices intended for use on patients. Now the regulatory bodies of Europe are acting to codify this priority into law. The MDR contains regulations for the following areas, among others:
There is also a new directive on in-vitro diagnostics in the works. This regulation will enter into force on 26 May 2022. The IVD Directive (IVDR) aims to provide greater safety and traceability of products throughout the product life-cycle and especially within the supply chain through new classifications, performance evaluations, quality-management systems and expanded technical documentation. From information for any departments and stakeholders involved in this area to internal communications or comprehensive training materials for all employees – it goes without saying that tolingo will of course provide you with reliable and competent support for your translation needs relating to the IVDR!
Above all, the new MDR is most relevant for manufacturers of medical devices which are sold in the EU. The new requirements stipulate that they must collect certain types of data on their products and make this available. Furthermore, they must pass this information on to the entire supply chain, all the way to the user or patient – using easy-to-understand wording and in all the necessary languages. Distributors and importers of medical devices operating in the European Economic Area will also be held accountable. Any company that distributes a product affected by the new law within a member state of the European Union is also responsible for providing the required documentation in accordance with the applicable requirements – unless the manufacturer provides this itself.
The manufacturer, dealer or importer responsible for adapting the products must make all information regarding this available to the responsible authority in the respective EU member state – the “notified body” – at least 28 days before the products are to be first sold on the market. Many companies involved in this process have reported that they found the requirements and stipulations within the MDR to be both extensive and stringent. However, they are undeniably appropriate and logical when one considers their significance for the user and for patient safety.
Thanks to more than 10 years of experience with the medical and pharmaceutical industry, tolingo is very familiar with the challenges of this sector. With our support, you will be able to solve all your translation needs easily and on time, so that nothing can stand in the way of your future success on the European market!
The Medical Device Regulation (MDR) will come into force on 26 May 2021, and all of its aspects will have to be taken into account in the distribution of new products in future – for medical devices already on the market, there is a notification deadline of 27 April 2021. Manufacturers and other stakeholders who fail to implement the requirements of the MDR by the deadline can expect to no longer be allowed to distribute their medical devices in the EU. In this case, the notified bodies have the power to arrange for distribution and use to be suspended until all the requirements have been met.
A ban on sales of this extent could result in a significant loss of revenue. For this reason, manufacturers as well as importers and distributors should note that the MDR also entails changes in the classification of medical devices. In other words, certain products that may not have been classified as medical products under the MPG may well be included under the new MDR. If your company is a manufacturer or dealer, you should therefore immediately review your entire range of medical devices in all classes (class III, class IIa, etc.) and verify whether certain documents need to be adapted and/or translated.
tolingo is a translation agency with many years of experience in the field of medical devices and pharmaceuticals; it works exclusively with certified specialist translators and is a pioneer in the translation industry with its triple ISO certification. We offer more than 220 language combinations and are always able to find the best solution for any challenge thanks to our extensive network and state-of-the-art technology. In tolingo, you’ll find a professional and competent partner in the field of translation services.
Would you like to have your medical content translated flawlessly and before the deadline passes? Our experienced project managers will be happy to advise you (free of charge and without obligation) about tolingo's services. No matter your needs, we’re sure to find the best solution for you – see for yourself and contact us today!