The new European Medical Device Regulation (EU 2017/745) came into force on 26 May 2021 and is now fully applicable. This is a significant improvement on the Medical Device Directive (93/42/EWG) and looks to improve the safety standards of medical devices across Europe.
Stricter standards for medical devices
This new regulatory framework is stricter and more demanding in terms of risk classes and monitoring of medical devices. It aims to harmonise standards and regulate the CE-marking process, also ensuring better post-market surveillance.
The CE mark is essential for anyone looking to market medical devices within the EU. Manufacturers will now need to take extra steps in order to receive this mark, one of which includes gathering additional data from clinical studies.
What is the purpose of the new MDR?
In recent years, weaknesses in the previous MDD framework had become apparent. Not only was it struggling to keep up with technological advances, but it was also a directive and not a regulation. This meant that the individual laws of different member states could override it, leading to inconsistencies throughout the EU. There was also a focus on approval instead of actual performance, and a lack of accountability.
The MDR looks to resolve these weaknesses. As a regulation, the framework applies to all member states regardless of differences in local laws, regulating the approval process across Europe.
Once approved, notified bodies will need to conduct annual audits in order to ensure that manufacturers comply with new regulations and ISO 13485:2016 standards. Assessment reports, known as ‘Clinical Evaluation Reports’ (CERs), will also be subject to stricter scrutiny, and previous CERs may no longer be acceptable.
As well as adjusting the regulations to meet technical and scientific evolution, the very definition of medical devices has been broadened.
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.
Along with in vitro diagnostic medical devices, pacemakers and medical scanners, other items like bandages, condoms, cosmetics and contact lenses now fall under this definition. This means that even more manufacturers will find that they now need to comply with these new regulations.
With stricter health and safety standards, these changes to the European regulatory framework are designed to ensure the safety and effectiveness of medical devices. This should make it easier and safer for patients and users to access these devices with confidence within the European market.
What does all this mean for manufacturers?
All documents relating to medical devices will need to comply with the new requirements. Labels must come with instructions for use (IFU), while technical documents need to include a description, specifications, verification and validation. They must also include references to previous and similar generations of the device, as well as a benefit-risk analysis and risk management.
From now on, all information about medical devices in Europe will be stored in a central European database called EUDAMED. Open to the public, this will not only allow authorities to record and exchange data, but will also improve transparency about products for end users.
Although the regulations are now in force, products certified under the previous MDD can continue to be marketed until May 2025. After that, these devices can no longer be sold or distributed within any part of the EU. As such, companies must use this transition period to ensure that they comply with the new regulations.
Do you need to translate your medical device documents?
Under the new regulations, medical device documents must be translated into the official language of each EU member state where you will market your product. That means your documents could potentially need translating in up to 24 different languages. This new regulation is to help make sure that anyone within the EU can understand and use the product safely. This rule applies to everything from brochures and catalogues to IFUs and safety information.
Without these translations, manufacturers will no longer be able to sell their medical devices within Europe. For some documents like IFUs, translations will even be required as part of the initial assessment for CE marking.
Since all documents must be understood by everyone regardless of their native language, the translations must be clear and accurate. This is essential not just for compliance, but also for health and safety. By delivering quality translations of your technical documents, you can help customers use your products safely, delivering quality healthcare to as many people as possible.
With this in mind, make sure to choose a translation agency that is ISO certified. Doing so will ensure that they have the necessary processes in place to deliver accurate and up-to-date translations understood by your audience. This will in turn give you peace of mind that your products will not compromise the health and safety of patients and users.
At Intertranslations, we specialise in translating a range of medical documents for various medical supplies and equipment. By providing you with quality translations, we aim to facilitate the diagnosis and treatment of patients worldwide.
Our translators use specialist medical glossaries and databases, while also following all the latest regulations and guidelines. This way, we make sure that we deliver accurate and consistent translations to ensure maximum safety.
For anyone looking to expand into a new market, it is essential that you obtain a reliable translation free of any errors. When it comes to medical devices, the slightest mistake could have dangerous consequences, jeopardising the health and wellbeing of your customers.
That is why we use translators who are native speakers of your target language and experts within the medical field. Drawing on their extensive knowledge, they will choose the right terminology and wording to ensure your technical documents are clear, accurate and understood by all.
We also understand that time is of the essence in order to avoid any delays to market. Our team has a number of processes in place to ensure accurate and timely translations, helping speed up your journey to market.
Want to learn more about how we choose our translators and the processes we have in place? Our team would be more than happy to answer any of your questions, so feel free to get in touch!