A major change will take place on 26 May 2020: 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 manufacturers, dealers and importers of medical products on the European market, this will mean that all products will need to have been adjusted to comply with the regulations in this new policy and in the languages required within just a few months. Any organisation that has not adapted its business to comply with the various requirements of the MDR after that date will have to expect that they will no longer be able to sell their medical products in European countries. It is therefore all the more urgent to take advantage of the remaining months as soon as possible and adapt your medical products quickly (but still take care to do so properly)!
If you are a manufacturer, dealer or importer facing this issue, tolingo is very happy to offer its services for the translation of your medical products. We take into account not only the MDR (which will enter into force in May of 2020) but also the Regulation on in-vitro diagnostic medical devices (IVDR) which will be lapsing in May of 2022. 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 will collaborate with you in a highly organised and careful manner to ensure that our work meets all the text-related requirements for your medical products in the respective language.
With the help of the information and data contained in the MDR and the Regulation on in-vitro diagnostic medical devices (IVDR), we will quickly be able to guarantee that your medical products can continue to be sold in the important European Economic Area markets for pharmaceuticals and medical products. Last but not least, we can also provide support in other ways, such as producing instruction manuals that are not only compliant with the new regulations, but also easy for the user to read and understand.
The Medical Device Regulation (MDR) is an EU-wide corpus of requirements governing the handling of medical products. The European Commission reached an agreement on it as far back as 2017. However, a transitional period of three years (i.e. until 26 May 2020) was enacted in order for manufacturers of previously approved medical products to be able to fulfil the new MDR requirements. The German Act on Medical Devices (MPG) and the CE seal have been adapted to include the new additions found in the MPR directive.
The MDR imposes 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 MPG than (for example) the handling of pharmaceuticals. Yet a high level of safety is just as important for medical products that are to be used on patients or even implanted into their bodies. Now the regulatory bodies of Europe are acting to codify this priority into law. The MDR contains regulations for the following areas, among others:
The MDR is primarily directed at manufacturers of medical products who do business in the EU. These companies are subject to the requirements of gathering data on their products, as well as making that data available and accessible to the entire supply chain, all the way to the user and patient. The requirements also apply to dealers and importers working within the European Economic Area. Any company that distributes a product affected by the new law within a member state of the European Union is also responsible for the translation of the required documentation – unless the manufacturer provides this. What that means is reworking, adapting and translating the extensive documents that accompany products in order to comply with the new requirements.
The dealer or importer responsible for adapting the products must make information regarding this available to the manufacturer and responsible authority in the respective EU member state – the “notified body” – at least 28 days before the products are to be sold on the market. For medical products already on the market, that means a reporting deadline of 27 April 2020 at the latest. 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.
Manufacturers and other organisations that have not adapted their business to comply with the various requirements of MDR after that date will have to expect that they will no longer be able to sell their medical products in European countries. The “notified bodies” have the power to block these products’ use on patients until all requirements have been met. One potential result would then be a significant loss of revenue. That’s why it’s important for both manufacturers and importers or dealers to be aware that medical product classifications may change as a result of the MDR. In other words, products that may not have been classified as medical products under the MPG may well be included under the MDR. If your company is a manufacturer or dealer, you should therefore carefully review your entire range of medical products in all classes (class III, class IIa, etc.) and verify whether certain documents need to be adapted and/or translated.
tolingo offers many years of experience in the field of medical products and pharmaceuticals. Our agency also exclusively employs certified specialist translators. That means that when you work with tolingo, you know you have the best possible translation partner by your side. Feel free to contact us directly so that we can carefully adapt your products to the new regulations on medical products within the deadline!
When dealing with the requirements of the Medical Device Regulation, you can rely on one of the world’s leading translation service providers. We’d love to help you and will work with you closely to go through the modifications to your medical products!