How are medical devices regulated in the EU?

Medical devices and equipment are strictly regulated to ensure they conform to the expectations outlined by the EU Medical Device Regulation (EU MDR). This includes any instrument, apparatus, implant, material, or any other medical article intended for use by humans. Examples range from dental and surgical equipment to bandages and even furniture like treatment chairs and hospital beds. These regulations are set to ensure that every device will perform as intended, without causing any harm to the users or patients. 

There are a number of factors that need to be checked over before a device can be approved for medical use. The new EU MDR is set to come into effect from May 2020, bringing about a few significant changes faced by designers and manufacturers. Here, we’ll go through what the changes are, and how this will affect the industry.

What is the conformity assessment?

The new conformity assessment for medical devices will not only be applied to new products being developed but also to existing devices. This is to ensure that all the devices being manufactured and used by patients meet the new legal requirements. The assessment generally involves auditing the manufacturer’s quality control system and a review of all technical documentation regarding the safety and performance of the finished device. If these tests have been passed, the device can be stamped with the CE (Conformité Européenne) mark to prove it’s been thoroughly checked.

Before medical devices can even be considered for a conformity assessment, there are requirements that need to be met. These include:

  • General safety and performance: The benefits of the device must outweigh any risks and perform as expected. Supporting clinical evidence and investigation will need to be provided to prove this. The chemical, physical, and biological properties of the device also need to be presented and explained, along with any manufacturers information—such as instruction manuals.
  • Technical documentation
  • Device specifications

The new legislation has expanded on the items considered “medical devices” which need to be checked with the conformity assessment. For example, contact lens solution, hair and tattoo laser removal equipment, and liposuction equipment were previously not considered medical devices, but have now been added to the list.

Why is medical device translation so crucial?

The new requirements put forward by the EU means that translation will play an even bigger role than it already does. Stricter assessments—and the increased scope of what is considered to be a “medical device”— mean that manufacturers will need to work closely with translators through every part of the process. Previously, only the device would need to pass any testing for the CE mark. After this, the labelling and instruction manuals would be produced and the product would be launched, without any further approval process.

Now, technical documentation is included as part of the test. This means that manufacturers must have the necessary translations completed for the device’s documentation ready for the Notified Bodies to check, along with any labelling and packaging. This content must also be available on the manufacturer’s website. If the device is to be launched in a few different regions, or even worldwide, the instructions for use (IFU) and labelling will need to be available in the official language of each nation. Having IFU’s accurately translated is of paramount importance. Any inaccurate information could put the user at risk of harm and could also inhibit the effectiveness of the medical device.

Here at Global Voices, we have a network of linguists with specialist expertise in the medical device industry and its new regulations. Our medical device translators are experts in the field and have the relevant experience to provide the most accurate translations for manufacturers, ensuring that they meet legal requirements. Get in touch with our team today for more information.

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