May 26, 2022, marked the deadline for medical device manufacturers to comply with the EU MDR requirements. The main objective of this compliance mechanism was to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices…which ensures a high level of safety and health whilst supporting innovation.”
While the MDR has been in place since May 26, 2021, a transition period has been provided to ensure manufacturers can prepare their quality management systems (QMS) and technical documentation before applying to a notified body. Manufacturers have until May 26, 2024, at which point the MDR will be fully applicable to all medical devices. Those manufacturers who don’t certify under the MDF will not have access to the EU market. This could have a huge impact on health, supply distribution, and of course, revenues. As of April 2022, nearly 50% of manufacturers’ submitted applications had been refused due to incomplete applications, showing that there is an apparent lack of preparedness.
This concern has prompted companies to create dedicated teams focused solely on MDR requirements. These teams must address many aspects of the manufacturing process including production, labeling, distribution, and product safety. Pragmatyxs helps support our medical device customers with all aspects of labeling compliance from label creation, design and layout, and traceability. For medical device manufacturers, this can include contract manufacturers, private label and re-label partners, distribution points, and point-of-use healthcare providers. These products can go through a number of “hands” so to speak and require that all of those involved have a streamlined process to ensure the product and its labels are correct and align with all regulations.
If your organization has not achieved the labeling requirements for EU MDR, Pragmatyxs can be an extension of your team and help you meet the compliance requirements.