Impact of the EU MDR on Medical Device Manufacturers Labelling Activity

Publisher: The Insight Partners

The EU’s new MDR that is expected to get live by the mid of 2020, has major consequences for labelling in every single form.

Usually, manufacturers of medical devices get their labelling including Instructions-For-Use (IFU) flyers & content of their website done by separate teams - with the risk of inconsistencies within their content & inadequacies that is often followed by delays in product launch.

However now, with EU’s new MDR, device manufacturers will have a prospect of doing things differently, such as they will be able to make more use of e-labelling & e-IFUs.

Some the key essentials of the new EU MDR affecting enterprise labelling activity are been mentioned below:

• Information of the Product published over the manufacturer’s website should always be up-to-date, that also includes labelling content.
• UDI (Unique Device Identification) data should always be uploaded to the Eudamed database for every single device by 26th May 2020, along with the UDI needed over the supplies that will fall under the FDA’s labelling definition.
• With the developments getting in place IFUs now can be given in an electronic format for the first time, but, the manufacturers need to designate that by the means of a new symbol over the label that the IFUs have been published by them in electronic format instead of paper form
• Device labelling should also be provided electronically by the means of website and printed paper format.
• Details about the organization’s European authorized representatives’ symbol, name as well as address also needs to be provided over the label of the product.
• A new symbol needs to be included over the label categorizing the product as a medical device
• Added symbols must be added regarding the medical device’s reprocessing as well as safety.