Medical Device eLabeling & eIFU Requirements Under the EU MDR

The last time you purchased a product on Amazon, I am sure you eagerly opened the box and immediately sat down to thoroughly study the accompanying instructions for use (IFU), right? All joking aside, the instructions for use that ride along with medical devices are far from an afterthought. In fact, they are pretty darn important for patient and user safety and a key focus of your risk management efforts. Increasingly, manufacturers are opting to distribute IFUs electronically on websites, […]

The Role of Medical Device Economic Operators in Europe

Authorized representative. Importer. Distributor. Person Responsible for Regulatory Compliance. The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certainly keep regulatory professionals on their toes. The duties associated with these four roles are outlined in Articles 11, 13, 14, and 15 of both regulations, respectively. However, they can be somewhat confusing because there is significant overlap in what some of these so-called “economic operators” do. In this article, we will give you a rundown on what […]

Step Aside MDD – There’s a New Sheriff in Town: EU MDR

MDD is no longer in effect in the EU. Starting May 26, 2021 the EU MDR is the law of the land.

Step aside, MDD. There’s a new sheriff in town (metaphorically, that is). Four long years after it was first revealed to the world in 2017, the European Medical Device Regulation (MDR 2017/745) rode into town to take over as the new enforcer of all things medical device on May 26, 2021. Going forward, the Medical Devices Directive (93/42/EEC) is no longer the pathway to CE Marking and all manufacturers are expected to comply with the MDR. Now that MDD has […]

Latest EU MDR and IVDR Updates and Developments

Following are a series of articles covering key EU MDR and IVDR topics. Check back often for up to date news on which Notified Bodies have been designated, UDI, the European Commission implementation plan, timelines, and more. Which EU Notified Bodies Will Be Designated Under the MDR and IVDR? Most recent update: August 19, 2021 We have compiled a list of all Notified Bodies that are currently designated for each Regulation along with links to their scope of services. […]

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