Medical technology – a vital industry
Medical technology has long been an important branch of the German economy. Since the current coronavirus pandemic, however, it has been on everyone’s lips. With new EU regulations coming into force this year and next, the industry is also the focus of particular attention. In this blog article, we would like to provide you with the most important information on medical technology, the new regulations and, in particular, their impact on translations of the associated documents.
What do we mean by medical technology?
The special thing about medical technology is the combination of highly technical and medical expertise. Today, devices and procedures for diagnosing, treating and curing diseases can no longer do without technical aids: Be it the complex X-ray machine, MRIs, ventilators or a simple adhesive plaster or bandage. All products in the industry aim to improve the quality of life and increase the productivity of clinics and medical practices. And just as technology and medicine are constantly evolving as stand-alone fields, medical technology is also expanding. It is a very dynamic and promising industry that brings a particularly large number of new products onto the market. With around 12,200 patent applications for medical technology products, the European Patent Office in Munich received more applications in 2016 than for any other sector. Over 50% of sales are generated by the sale of products that have been on the market for less than three years.
25% of European medical technology manufacturers are based in Germany. With an overall export ratio of around 65%, the industry’s international business is of central importance. The industry is also an above-average driver of the economy in Germany itself. Turnover of € 30 billion was generated in 2018.
The industry in Baden-Württemberg
Incidentally, medical technology is also extremely important in our home state of Baden-Württemberg: with 25% of national sales, the state is the leading medical technology location in Germany. Special expertise in the fields of endoscopy and high-quality surgical instruments are of international importance. A total of 1,104 companies in the healthcare industry (including 851 companies in medical technology alone) can rely on 44 research institutes and universities as well as 5 university hospitals (see BIOPRO). This makes our country virtually predestined for this industry. Since 2020, 181 start-ups have been reported in the healthcare industry alone.
New EU regulations
The new EU regulations MDR (Medical Device Regulation) and IVDR (In-vitro Diagnostic Device Regulation) have been in force since May 2017. They replace the IVD Directive 98/79/EC and the Medical Device Directives 93/42/EEC (MDD) and 90/385/EEC (AIMD). The latter two will be combined in just one regulation, the MDR. After a transitional phase to allow the necessary adjustments and re-certifications to be made in accordance with the new requirements, the MDR will enter into force on May 26, 2021, and the IVDR on May 26, 2022.
These extensive changes were triggered by the PIP scandal in 2011: due to burst breast implants from the French manufacturer, it emerged that no high-purity medical silicone was used, but instead cheap, unauthorized industrial silicone, which poses considerable health risks and hazards in the event of material leakage.
In short, these new regulations are aimed at increasing patient safety for medtech products. Due to the increased requirements and thus significantly increased costs for re-certifications, new appointments of responsible persons and more, the new regulations have come under heavy public criticism from industry and professional associations. On the one hand, there are fears that certain medical products will no longer be available in sufficient quantities at times, and on the other hand, the new regulations pose almost insurmountable challenges for SMEs, which are represented in the industry in large numbers, which in turn jeopardizes the existence of these companies.
New requirements for technical documentation
In addition to new, significantly increased requirements for quality and risk management, new classification categories, more extensive details on clinical evaluations and the introduction of a unique device identification number (UDI), the focus is particularly on technical documentation. The requirements for this have become much more detailed and include, for example, continuous updating to the latest version (and the associated translation of adapted sections) as well as its retention for 10 years (previously 5).
Requirements for the language of documents and their impact on translations
The most important change, which also has an impact on the translation process, is that some translations, including IFUs (Instructions for Use), are considered part of the technical documentation and must therefore be prepared before CE certification (conformity assessment procedure). It is therefore important for manufacturers to note that translations must be scheduled earlier than before.
Another new requirement is that all information relating to the product must be available in every official language of the country in which the product is marketed and used. All information must be “easily legible and clearly understandable for the intended user or patient” (EU Official Journal L 117). At the request of the competent authorities, it must also be possible to provide all evidence of conformity, clinical investigations, assessments and more in the official language of the authority.
product names must also be translated, for example, if they provide information on the use of the product. Each medical device must be available with all information in the respective national language in order to clearly identify the device and its function.
In the case of the translation of medical device software, it must be clarified on a case-by-case basis whether it is necessary. However, manufacturers should ask themselves at an early stage whether or not this needs to be translated so that they can act in good time if necessary.
Which language is accepted for technical documentation is determined by the individual countries themselves. While most countries only allow their one official language, the Netherlands, Cyprus, Finland and Iceland only accept documents intended for professional use in English.
Caution in multilingual countries (including Switzerland): In some cases, translations are required in all official languages! In addition, it has been newly regulated for Iceland that patient-relevant documents in Icelandic are mandatory.
Depending on how and in how many countries a product is distributed, translations in up to 24 languages may be required.
COMLOGOS helps you obtain certified translations
Due to the high technical demands and the compelling need for an exact and terminologically correct translation that is understandable for all target groups, manufacturers cannot avoid looking for a certified partner such as COMLOGOS in order to meet all the quality requirements of the regulations.
Thanks to our ISO 17100 (requirements for translation services) and ISO 9001 (quality management) certifications, we can provide you with high-quality, certified translations with the help of our highly trained native-speaker specialist translators. Our work with a translation memory system and our range of terminology management guarantee consistent, high-quality translations that meet the quality requirements of the medical technology industry.
But watch out:
Not every translation service provider that works according to ISO 17100 is automatically certified! Read our article on “Certification vs. registration according to ISO 17100”on how to make the right choice.
Still have questions?
If you have any further questions about the industry, our range or our certifications, please do not hesitate to contact us at mail@comlogos.com or by telephone on 0711-34 24 56-0.
