Much like the experience we have all recently gained in the United States during the deployment of UDI for Class 3 and now Class 2 devices and soon Class 1. The goals of the European Medical Device Regulation (MDR) and In-Vitro Diagnostic Directive (IVDR) are to provide for the safety and well-being of the consumers […]
The European Commission legislation is introducing new compliance requirements on medical devices and creating completely new medical device regulations (MDR). Following in the footsteps of the Food and Drug administration of the US, EU has decided to adopt the Unique Device Identifier (UDI) for all medical devices and In Vitro Diagnostics (IVDR). This will be […]
UDI requirements for class 3 and class 2 devices are now behind you, but the compliance standards continue to emerge and you must maintain the ones you have already completed. Maybe your organization is impacted by all three (3) UDI class distinctions, or MDR (European UDI) standards, or you have additional requirements to maintain these […]
Several dates for UDI compliance have been postponed: • Class I and unclassified devices – 24th of September, 2020 • Direct Marking of Class I and unclassified devices – 24th of September 2022 Low-risk devices are required to follow the UDI ruling two years later than it was originally planned (24th of September 2018). Class […]
The Pragmatyxs family would like to send our sincerest condolences to Puerto Rico during these tough times and offer our hand in assisting in any way possible. Please know you are not in this fight alone. If your business or personal matters have been affected by these natural disasters please reach out to Pragmatyxs […]
FDA announced this week a list of more than 1,000 medical devices that will now be exempt from 510(k) notification requirements — a move that aims to help speed up the process of bringing new medical devices to market. The decision was made this week in accordance with a process laid out by the 21st […]
Last week we discussed the extension the FDA has granted on the Unique Device Identifier (UDI) Class II Mandates. Similar to the extension there are also exceptions on single use devices that medical manufactures should be aware of. The exception states that if you put a (UDI) on the next higher level of packaging you […]
The Association for packaging and processing technologies, examined the latest trends impacting the pharmaceutical market. Global sales in 2016 have reached a record high for pharmaceutical sales at $1.1 Trillion, with North America alone generating $574 billion. The greatest influence on growth in the pharmaceutical industry is general economic development. As more people can afford […]