The transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) is one of the biggest challenges facing medical device manufacturers today. In this video, Linda Chatwin, Esq. UL's RAC explains what companies can do to prepare for the transition to the stricter requirements of MDR.

In most cases, MDR demands more from medical device manufacturers. Companies will need to conduct gap assessments to anticipate where they will fall short ahead of the MDR deadlines. However, it is not only the manufacturers who will have to adapt, it is also the Notified Bodies (NBs) with which they work. All NBs will need to recertify and now it is time to determine if your current NB is adaptable enough to meet the new requirements.

A big demand from medical device manufacturers will be the use of unique device identifiers (UDIs) and an associated database. The European Medical Device Database (EUDAMED) will include every device on the market and manufacturers are required to report serious incidents and field safety corrective actions to the database.

Watch the video in full to learn more about the requirements for manufacturers, changes to NBs and how CE markings work under the new rule.

To prepare for the upcoming changes to the EU MDR regulations, download our Industry Brief, click here: http://bit.ly/48299it

You can also read the latest news about the EU MDR on our website https://www.mastercontrol.com/compliance/eu-mdr/?utm_campaign=7013x000001y6ZMAAY&utm_medium=PR-AR-Social&utm_source=YT

Read an expert's tips for a successful EU MDR transition here https://www.mastercontrol.com/gxp-lifeline/6-tips-for-a-successful-transition-to-the-eu-mdr/?utm_campaign =7013x000001y6Z6AAI&utm_medium= PR-AR-Social&utm_source=YT

EU MDR: how will Europe's new device regulations affect software https://www.mastercontrol.com/gxp-lifeline/eu-mdr-how-will-europe-s-new-device-regulation-affect-software/ ?utm_campaign= 7013x000001y6Z6AAI&utm_medium=PR-AR-Social&utm_source=YT

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