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SELECT LANGUAGE:
This piece is part of Lionbridge's series addressing language challenges under the new medical device regulation (MDR) in the E.U. which applies from May 26, 2021. In this blog, we focus on the requirements for medical device implants.
What is an implant card and why is it important?
Implant Cards (ICs) are a source of truth for patients with permanent or semi-permanent medical devices in their bodies. They help the owner of the device make informed decisions about their healthcare, and they are also critical for healthcare providers.
In an emergency situation in particular, information about a patient's implant is crucial to provide safe, effective care. The cards are generally wallet-sized and can warn about potential interactions with imaging systems, like MRIs, or the likely need for aggressive antibiotics, as in some joint replacements.
What information is required on implant cards?
Current requirements for implantable medical devices or systems cards include symbols based on ISO. This information identifies the patient, provides an informational website and details certain particulars:
- device name
- serial number
- lot number
- unique device identifier (UDI)
Missing from that list of fields with ISO symbols is device type. The new regulations require this addition in the language(s) required by the relevant Member State. This additional information could be provided with a sticker system on preexisting cards or by printing the information on the card itself.
Because manufacturers are required to provide instructions on IC completion, the MDCG recommends including an informative instruction leaflet that explains the symbols and fields. Again, these leaflets are likely needed in multiple languages, as the E.U. has 24 official languages.
Where are implant cards required?
The E.U., Australia and the U.S. all have some overlapping requirements for implant card information. That means it’s possible to multitask when creating implant cards by simply including the card with the most requirements.
The linguistic burden of the new MDR also impacts these implant cards. In general, the regulation stipulates that the cards be produced in the language of any market where they are distributed.
How can language management simplify business for implant manufacturers?
The range of requirements and languages across geographies create a complex regulatory environment for any medical device manufacturers. Rather than struggle to keep up with changing laws on their own, companies can partner with a knowledgeable LSP like Lionbridge as they make sure their devices are well documented and pass muster for new codes. Get in touch with us today to learn more about how we can help.
