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 Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on extending the recognition of EU CE marked devices in Great Britain indefinitely. The consultation seeks ...

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 ...

The "3-Hour Virtual Seminar on US FDA and EU Medical Device Directive Requirements for DHF, DMR, DHR and TF/DDS" training has been added to ResearchAndMarkets.com's offering. This webinar will examine ...

Any medical device manufacturer seeking to enter the European market will need to use the services of a notified body in its quest to obtain CE marks for its products, which allow those products to ...

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 ...