Working on compliance with the new EU Medical Device regulation?
Skrivanek can help with translation.
The European Union (EU) has long maintained rigorous standards for medical device translations, championing clear and linguistically accurate instructions for product users in European markets.
Effective May 26, 2020, those standards will be further fortified through the mandatory application of the EU Medical Device Regulation (EU MDR), which will replace the Medical Devices Directive (MDD) currently adopted by EU member states. The EU MDR places a more stringent focus on translation and linguistic validation processes in the medical device industry, including application of linguistic standards to a wider range of medical devices, and guidelines for more thorough labels on products.
There are over 500,000 types of medical devices on the EU market, including pacemakers and x-ray machines, along with a host of in vitro devices used to perform HIV blood tests, pregnancy tests and others. Misuse of any medical device could result in dangerous and life-threatening outcomes for patients, the likelihood of which enforcement of the new EU MDR is geared toward lessening.
Skrivanek’s experience in translating for the medical device industry spans more than two decades and features projects of significant scale with some of the world’s leading medical device manufacturers, including Philips, GE Healthcare and Siemens medical.
Contact us today to ensure full compliance with the new EU MDR.
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