The two-digit numbers at the beginning of the directives indicate the year in which the text was published in the Official Journal of the European Communities (OJ); it can be concluded that there was ...

The question of why to translate, as it relates to user safety information for medical devices, is answered easily initially: because it is required. Most major healthcare markets have strictly ...

Already under the current MDD regime, medical devices, such as stand-alone MDSW, are classified according to their intended purpose and their inherent risks, and are divided into the following four ...

The EU’s new regulation on medical devices finally came into full application today, following a year’s delay due to the COVID-19 pandemic. According to the European Commission, the Medical Devices ...

Medical device recalls are a difficult aspect for medical device manufacturers and distributors, and most importantly, with the end users of these devices. Balancing the needs of the users along with ...

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains ...