Today, the EU Medical Device Regulations (EU MDR) became fully applicable, a year later than initially planned and just over four years since the finalized text was published in the Official Journal of the European Union.
In August 2017, just a few months after its publication, we conducted a survey of medical device manufacturers which revealed just 17% of respondents were aware of the changes that lay ahead despite 72% of them believing the new regulations would have a major impact on their business.
Since that time, PRISYM ID has been helping the medical device industry understand the looming seismic change to the regulatory landscape, providing support and guidance on how to adapt labeling solutions and ensure compliance.
With focus now turning to the transition deadlines in 2024 and 2025 when devices approved under the Medical Device Directive (MDD) – EU MDR’s predecessor – can no longer be placed on the market or put into service; many manufacturers are still grappling with decisions over how they might transition their existing product portfolio. It is for this reason, therefore, that many are still in the early stages of their EU MDR compliance journey.
Our whitepaper, Simplifying the Path to EU MDR, provides a comprehensive overview of the new requirements for labels, packaging and Instructions for Use (IFUs). Earlier this year, to mark 100 days to go, Richard Castle, Global Account Manager - Medical Device, published a blog outlining the scale of the challenge facing medical device manufacturers and gave five key recommendations for effective implementation and how to prepare for change.
In the coming months and years, PRISYM ID will continue to support medical device manufacturers with their implementation efforts, adding to the wealth of resources already available on our website (Please be aware that some of these were produced prior to delay in application, therefore timelines referenced may no longer be accurate):
- EU MDR Checklist
- EU MDR – Touch your label once
- Medical Device Label Before and After EU MDR – 10 Sticking Points
- 5 Key Learnings – The Clock is Reset…Opportunity for your Organization to Re-Evaluate Compliance to EU MDR Labeling
In partnership with KPMG, we explored how the 12 months delay to EU MDR due to the pandemic created new opportunities. We also published a summary blog of the discussions.
- EU MDR: Best Practices for UDI Data & Product Labeling
In partnership with Reed Tech, discussions focused on device registration, UDI data management and product labeling.
- EU MDR Labeling – ‘Touch Your Label Once’ Strategy
During this session, PRISYM ID experts discuss the increased adoption of ‘touch once’ strategies where a wholesale redesign of global labeling processes occurs all in one go.
- EU MDR’s Impact on Labeling: UDI in Europe and Other Changes
In addition to discussing EU MDR’s impact on labeling, the panel explored submission requirements of the new EUDAMED database. We also published a summary blog of the discussions.
- EU MDR Labeling Compliance: Learn the Lessons from UDI
An exploration of how EU MDR builds on the FDA’s UDI requirements and the additional complexities due to local language requirements.
About the author
Warren Lesack, Global Sales Manager Medical Devices, PRISYM ID
Warren Lesack is an accomplished global sales leader with over 20 years of sales and management experience in various industries. A U.S. Army Veteran, Warren’s work experience spans several industries including Medical Device, Hazmat, and Financial Services, all of which are heavily regulated. Warren has a proven record of implementing compliant software solutions to his clients that have helped to create efficiencies, reduce risk, and increase profitable growth.
Warren is an avid soccer fan and enjoys spending time with his family on and off the pitch or playing guitar.