Meet the MDR and IVDR compliance requirements by developing a translation strategy hand in hand with a reliable language service provider
The EU’s Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR) are now in effect. Are you a medtech manufacturer seeking to place your products on the European market? That being the case, it’s time to acquaint yourself with these new standards.
– What is MDR and IVDR?
MDR and IVDR are the new European medical device regulations applicable across the 27 EU Member States. They came into force on May 26, 2021, and May 26, 2022, respectively.
They set new requirements to create a more transparent regulatory framework meant to:
- Ensure the safety and performance of medical devices.
- Enhance their traceability.
- Boost post-sale surveillance during the life cycle of the product.
- Safeguard patients and users.
- Protect public health.
– What is the difference between MDR and IVDR?
- MDR
The Medical Devices Regulation 2017/745 applies to any medical device manufactured or supplied in the EU. It replaces the previous Medical Devices Directive (MDD) and Active Implantable Devices Directive (AIMDD).
The MDR requires a Clinical Evaluation Report (CER) for any medical device to enter the European market. Once marketed, devices undergo continuous clinical monitoring.
- IVDR
The In Vitro Diagnostic Medical Devices Regulation 2017/746 covers tests used on biological samples to detect disease, conditions and infections.
The IVDR requires a much more thorough performance evaluation than the previous In Vitro Diagnostic Medical Devices Directive (IVDD).
Your device will be subject to a conformity assessment involving an independent third party known as a notified body.
– What aspects of the MDR and IVDR have led to a surge in demand for translation services?
The EU is multilingual by nature. So, language plays a key role in placing medical devices on the European market.
Even more so since the new regulations came into effect.
Under the MDR and IVDR, you must ensure that patients and users fully understand medical devices safety and performance information. This applies to labeling, packaging and instructions for use (IFU).
Transparency is thus a must, which has crystalized in:
- A wider variety of contents throughout the life cycle of devices
Besides labels and IFUs, among the documents to be translated are:
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- Summary of Safety and Clinical Performance(SSCP).
- Implant cards.
- EU Declaration of Conformity.
- Post-market reporting.
Now, you’ll have to check with competent authorities when each type of information requires translation into local language(s).
- New requirements on public access to medical device information
The new regulations place emphasis on the need to disseminate information on performance, safety and adverse events across different target audiences. Which means users with different levels of technical knowledge, language and literacy.
As a result, you’ll have to produce and translate increasing volumes of technical and plain language content.
- Increased responsibilities for economic operators
Leaving manufacturers aside, there are three legal entities designated as economic operators under the MDR and IVDR:
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- Importers
- Distributors
- Authorized representatives
Each one of them has specific obligations when it comes to record-keeping, reporting or handling of the product.
For example, importers and distributors should check compliance on labeling and other information supplied with the device. They may also translate IFUs.
- Interdependence across the technical dossier and post-market surveillance
This calls for updated translations and follow-up on local language documentation throughout the device life cycle.
– How does the risk classification of an in vitro diagnostic device (IVD) relate to translations?
Under the EU IVDR, IVDs are classified based on two factors:
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- The risk of an incorrect result from the analysis.
- Their perceived risk to the public.
The risk classification determines whether an IVD requires conformity assessment by a notified body. It also establishes the level of premarket and postmarket control the IDV will be subject to.
In a nutshell, the higher the risk, the greater the need for content and translations.
– What are the new translation requirements set out in the MDR and IVDR?
Here are some key points to take into account:
- Clarity, relevance and readability
Content must be user-focused. That is, the language must match the understanding expected from the intended user. This implies differentiating between:
– A more technical approach for healthcare professionals.
– Plain language when creating content for “lay people”. That is, individuals who don’t have formal education in a medical discipline.
- More languages
Technical documents must be available in the languages of the countries where you intend to market the product.
Depending on your distribution objectives, you may have to translate your content into the EU’s 24 official languages.
- EUDAMED
This database providing an overview of all medical devices sold in the EU is available in all official Union languages.
Its goal is to enable fast, transparentidentification and tracking of devices. Manufacturers upload a Unique Device Identification (UDI) code, which will be shown on every product label.
- Translations before CE marking
Translation of documents such as IFUs must now be provided as part of the file for conformity assessment, before marketing and distribution.
– How to go about your MDR and IVDR medical translation projects?
The wide range of regulated content and official languages can be a barrier to entering the EU.
That’s why you should start by determining:
- The risk classification of your medical device.
- Its intended use.
- The launch territories.
The next step is to find a scalable language service provider that can keep up with the increasing translation demands imposed by the EU.
Your translation partner must have experience in the medical field and be knowledgeable about clinical and regulatory aspects. This is crucial to ensure that your medical device obtains the CE mark needed to sell on the European market.
Looking for a trustworthy translation provider? Check out our certifications, which come to prove our commitment to quality.
