Author: Gary Saner, Sr. Manager Information Solutions, Reed Tech
Are you as a medical device manufacturer, in the middle of preparing for the EU Medical Device Regulation (MDR) and trying to figure out your response to the European Commission’s notice that the EUDAMED launch is delayed two years from May 2020 to May 2022?
You are not alone, although according to a survey conducted by Reed Tech on Nov 13, 2019 most of your colleagues have already decided to continue preparations. Only 2% of the respondents indicated they will postpone all preparation activities.
Most manufacturers (60%) realize the significant effort to transition from the Medical Device Directives to the MDR and decided to continue the MDR preparation activities. They understand the MDR “process” is not delayed and MDR documentation and device registration previously expected to be reported to EUDAMED must still be reported per corresponding Directive provisions in the two-year period.
If you haven’t started EU preparation, accept the break and continue to make progress. Transitioning to EU MDR/IVDR is a huge task and needs significant time and effort. There are multiple EU MDR/IVDR implementation steps including:
- Understanding the regulations
- Determining your requirements
- Identifying gaps
- Creating/executing a plan
- Preparing procedures/data/systems
- Preparing MDR documentation
- Engaging a Notified Body and securing assessment approvals
- Registering your organization and devices
- Updating labels and more
Reed Tech provides valuable help in preparing for EU MDR/IVDR prior to the MDR DoA and through the two-year EUDAMED delay.
Looking to future needs beyond EU UDI, Reed Tech continues to work on UDI solutions supporting additional global regulatory requirements (e.g. South Korea, Saudi Arabia, China and others.) Contact us to explore how Reed Tech can help you meet your global Medical Device UDI data management challenges and requirements.
Contact us: MedDevice@ReedTech.com