The global medical devices market was valued at USD 489 billion in 2021 and is projected to grow to more than USD 700 billion by 2029. Europe is home to two of the largest importers of medical devices in the world and makes up the second largest medical device market after the US, with 27.3% of global trade. On 26 May 2021 – amid supply line challenges and with the world still reeling from war and high inflation – a new medical devices regulation (MDR) came into force. Compliance with this will be compulsory for producers and resellers of medical devices sold on any European market. Read on to find out what the key language requirements of the new regulation are and how they may affect you.
Big import market for medical devices
In Europe alone the medical technology market was estimated to be worth about EUR 150 billion in 2021, and despite a setback following the credit crunch of 2008, average growth over the past 10 years has been 4.8% per annum, with a growth rate of 2.9% in 2021.
The average spending in Europe on healthcare is around 11% of GDP, with 7.6% of that spent on medical technology, including medical devices. Additionally, out of the 15,300 patents filed with the European Patent Office, 41% were home-grown, i.e. from the UK and EEA or EU member states. 38% came from the US and 21% from other countries. As mentioned above, in 2021 two European countries – Germany, with USD 11.9 billion, and the Netherlands, with USD 11.7 billion – were the top importers of medical instruments in the world after the United States.
This means that not only is there a solid level of innovation, development and sales of new products across borders within Europe, but it is also extremely lucrative to sell medical devices into the European market.
The medical devices regulation
For producers or resellers of medical devices wishing to carry out imports or sales within the EU, regardless of whether they are based within an EU member state or do not belong to the EU (for example, the United Kingdom), compliance with the Medical Devices Regulation (MDR – also known by its full name of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices) will be mandatory.
The most notable difference between this regulation and the directives it replaces is the scope. Whereas previous directives stated that “This Directive shall apply to medical devices and their accessories,” the MDR is wider in what it encompasses:
“This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.”
The term “medical device” is defined as any instrument or apparatus, including software, etc., that the manufacturer intends to be used, either on its own or in combination with other products, for medical purposes. In addition to medical devices and accessories, the scope of this new regulation now incorporates any clinical investigations related to such equipment.
It also covers “Devices with both a medical and a non-medical intended purpose,” but excludes “in vitro diagnostic medical devices covered by Regulation (EU) 2017/746” as well as certain medicinal products such as blood, tissue or anything of animal or human origin.
The language requirements
Apart from the wider scope, another key difference is the enforcement of language requirements. Whereas the requirements are not substantially different from the directives it replaces, the MDR makes them more explicit. The previous regulation says that member states “may require” translations to be made into the various languages of the member states, but in MDR, Chapter IV, Article 41, under the heading “Language requirements,” it says,
“All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned.”
Note the subtle but distinct evolution from “may require” to “shall be”. In other words, this is not optional and producers and resellers should not wait for a request to be made.
Again, in Annex II, part 2, you find the following wording under the heading “Information to be supplied by the manufacturer”:
“A complete set of:
the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.”
In Article 41 the phrase used is “determined by the Member State concerned” and in Annex II it is “languages accepted in the Member States where the device is envisaged to be sold”.
Additionally, in Annex XV, part 3.1.5 we find the requirement for the synopsis of clinical tests to be “…in an official Union language determined by the Member State concerned”.
So not only does the new regulation cover more ground – clinical tests/investigations in addition to the medical devices and equipment – it also makes the requirement more explicit and specific: you shall provide documentation in the language that the relevant country requests, but the onus clearly has shifted on to you, as the producer or reseller, to ascertain what this is and to have it ready.
In Article 26 the regulation also mentions the need to comply with “…the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33”. Implementation of this database has been plagued by delays, but is now planned to be in full operation by the second quarter of 2024. For this purpose, the Commission will make sure internationally recognised medical devices nomenclature is available free of charge to manufacturers and others who are required to use this terminology. It is worth checking if this applies to any of your products or processes in order to avoid having to make changes when the time comes.
Medical devices and Brexit
The MDR came into effect after the United Kingdom left the European Union and after the transition period stipulated by the EU (Withdrawal) Act 2018. As such it does not and will not apply in Great Britain. However, since 26 May 2021, the EU MDR has been applicable in Northern Ireland under the terms of the Northern Ireland Protocol.
Medical devices intended for sale in Great Britain, including in-vitro devices, custom-made devices and systems or procedure packs, must be registered with the MHRA and conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023). In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted in Great Britain until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.
In practice, this means that there isn’t a big difference in terms of language requirements – the labelling and compliance marking is broadly the same and other documentation must obviously be in English in order to obtain the MHRA registration. The difference may, however, be felt by British producers or resellers seeking to sell on the European market, as they will have to ensure that all relevant texts are in the respective languages of the countries they are going to be selling to.
The need for speed and accuracy
When importing or exporting medical devices or conducting trials in accordance with the regulation, documentation must be provided in the language requested by the country you are selling to. These documents need to be ready, or at least capable of being ready, in time for you to fulfil your side of the contract at the time you are signing on the dotted line of the deal.
But there can be little doubt that when dealing with instructions for use or crucial information about medical devices and accessories, or indeed technical information sheets or summaries of a trial of any such equipment, accuracy is of the highest importance. When texts need to be translated from one language to another, you need to guarantee that your language vendor has the required expertise and technology to manage technical and corporate terminology for all your multilingual content effectively.
In 2007 it was discovered that 47 knee implants had been applied wrongly in knee operations in Germany. The reason? An incorrect translation of the English term “non-modular cemented” into German as “non-cement” or “without cement”, by what the report calls “hospital staff”. In this case, it could be argued that had there not been a legal requirement to translate it, the misunderstanding would never have occurred. EU regulations as well as individual countries’ regulations are no better than the quality with which they are implemented. Complying with MDR language requirements can certainly be a complex, expensive and time-consuming process, but it’s the chosen way to keep developing a global market while simultaneously guarding and protecting patients’ safety, and quality-assured translation will contribute to fulfilling that purpose.
Talking of consistency, the requirement mentioned in the MDR for consistency of terminology will only be greater when the EUDAMED system is fully operational. This can be ensured with the help of glossaries, term lists and approved terminology applied during the translation process, which can then be reapplied to subsequent translations, thus saving turnaround time without sacrificing accuracy or introducing inconsistencies.
A healthy bottom line
The European market for the import of medical devices, equipment and accessories is a high-value one. The expressed aim of the MDR is to reduce regulatory diversity and give greater clarity as to what the requirements are, including the need for you as a manufacturer or reseller to make sure that instructions for use, compliance information, summaries of trials, warnings and notices, and all other relevant information, is translated into the language or languages of the country you are selling to, as determined by that country. Some countries with more than one official language may require translations into all languages used.
As we have seen above, accuracy is of the highest importance when dealing with products of this kind, but commercially, speed is also of the essence. Working with a high-quality, experienced language service provider will give you the best of both of these worlds and contribute not only to patient health, but also to a healthy bottom line.