Innovia Medical has been hard at work for the past year preparing to be compliant with the European Union’s Medical Device Regulation (MDR) effective May 26, 2021. MDR replaced the EU Medical Devices Directive that was previously in place and establishes a regulatory framework for medical devices that safeguard public health and safety.
To maintain compliance with MDR, our Minnesota (Summit Medical) and Ripon (Network Medical) locations have updated their instructions for use (IFU) to include disposal instructions, intended users, serious incident reporting, and standardized symbols. They also added the relevant IFUs to a database on their product websites:
The IFU databases will allow website visitors to view and download the most up-to-date IFUs on a phone, tablet, or computer. Users can also search for previous versions of the IFU, in some cases exceeding the shelf life of the product.
Shipping and box labels have also been updated with the standardized symbols, translations and distributor information where relevant.
So far, Innovia Medical has made the above updates to their InstruSafe, Denver Splint and Ophthalmic PVA & Cellulose product lines with Vent Tubes, Ear Poppers, PVA Nasals, Epistaxis Catheters, and Filtrons in the works.
At our Swansea location (DTR Medical) we are also in the process of adding both our active and archived IFU’s to the website; these will be freely available to view and download shortly. Our technical files have also been reviewed to ensure we conform to the MDR guidelines and meaning we will be able to continue to supply with our DTR Medical brand single-use surgical instruments.
We want to hear from you!
Are you currently purchasing from Innovia Medical? As part of our compliance, we are looking to attain your feedback on our products and services. We have surveys that can be completed both electronically and via paper copies. If you would like to participate in our survey, please contact us at firstname.lastname@example.org.