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 the biggest change since the 1990s and will help restore the confidence of patients, consumers and healthcare professionals in the safety of medical devices.
The EU MDR/IVDR legislation impacts the whole lifecycle of medical devices that are marketed in Europe. Beginning with the developing and registering of devices, manufacturing the device, packaging, post market surveillance, recalls, and discontinuation. This will require your business to adopt many new business procedures and capabilities.
EU MDR will have the biggest impact upon labeling requirements, regulatory affairs and packaging design . Processes to implement new capabilities (e.g. business processes, IT systems, facilities) is the biggest factor in obtaining a compliant solution.
Pragmatyxs has been trusted by many fortune 500 medical manufacturers to help develop an Enterprise Compliance Labeling Solution for their global operations that will meet FDA and EU regulations. We have the experienced resources that can assist your company to comply with these new mandates. If we have learned anything from our experience in deploying UDI compliance systems, don’t hesitate, it’s time to act now!