EU Medical Device e-Labeling Archives

EMA releases updated QRD Style Guide– say no to “drugs”

October 11, 2022/in EU Medical Device e-Labeling, Life Sciences/by Brenda Stoltz

The European Medicines Agency (EMA) is responsible for evaluating, supervising, and monitoring medicines for safety– its mission is to foster scientific excellence in the assessment and management of medicines in the EU. Committed to providing clear and unbiased information, the EMA employs a variety of regulatory mechanisms that are continuously evaluated and optimized for the benefit of the public.

The EMA recently published its compilation of Quality Review of Documents (QRD) decisions about the stylistic guidelines in product information– citing frequent translation issues and providing additional policies that directly impact multilingual labeling and packaging.

EU MDR changes and language translation: are you ready?

November 19, 2019/in Document Review Services, EU Medical Device e-Labeling, Medical Device Labeling, Medical Translation/by Angelo Passalacqua

With the new year comes the implementation of the European Union Medical Device Regulation (EU MDR). Consisting of complex and sweeping changes, the new regulations, guidelines and enforcements are more stringent than its predecessor, the Medical Devices Directive (MDD). Released in 2017, medical device manufacturers were given a three-year transitionary period – with the new regulation taking effect May 26, 2020.

Understanding EU medical device e-labeling requirements

January 23, 2014/in EU Medical Device e-Labeling/by BURG Translations

Now that the European Union is moving toward e-labeling for medical devices, companies like yours are able to reduce the cost of delivering pertinent product and safety information. Digital delivery of label information ensures that product users always have up-to-date product information, which can even be delivered via video.