Preparing Your Team for the EUDAMED Database
John N. Bradsher, PhD, RAC, Medical Device Regulatory Affairs & Quality Assurance Expert at Celegence will present a webinar: How to Start Preparing your RA/QA Team for the EUDAMED Databse on Tuesday, September 22 at 10 a.m. CST. Read on for John’s perspective on the importance of EUDAMED in a pre-event speaker interview.
Does the implementation of EUDAMED mean that RA/QA teams must implement an entirely new internal process?
Yes, there are several new processes:
- All EOs must create and maintain a database of UDIs for class III implantables, and for any devices to be detailed in Implementing Acts. User Facilities must maintain the same information of these 2 crucial product areas (A 27)
- Assignment of BUDI-DI to devices and device groups (A 29)
- SRNs must be assigned for each Economic Operator. Bear in mind that this will also probably involve fee payment to Competent Authorities (A 31)
- SSCPs will be needed for class III and implantable devices, and these will need to be stored in EUDAMED (A 57)
- If the manufacturer is conducting Clinical Trials in the EU, a Single Identification Number and additional requirements will need to be met (A 73)
- Any User Facility that reprocesses single-use devices will become a Legal Manufacturer in their own right. (A 17)
What are the benefits of planning and preparing for EUDAMED well before the deadline?
EUDAMED modules will come online before the entire database functionality is complete, and then, expectations of the manufacturers will follow with compliance expected. In some instances, this could be as soon as 6 months after the notification of module functionality.
Those manufacturers that are marketing legacy devices and are unable to meet the deadlines for compliance with various modules may find their certifications being revoked. For manufacturers that are intending to market on MDR certificates and fail to have these obligations in place, you can predict a long and protracted audit with lots of findings, and it may fail altogether if the situation is not corrected.
The unknown element in all of this is Brexit, which continues to look like the UK will fall out of the EU without a customs agreement by December. In such cases, manufacturers may be able to market in the UK beyond May 26, 2021, but it is simply too early to say with any confidence.
There are also benefits to being able to unfold an overall strategy for compliance that is proactive rather than reactive in order to build up the resources needed for the compliance effort.
Why is it vital for manufacturers to have a thorough understanding of the EUDAMED database?
The EUDAMED database will be one of the fundamentals necessary in the QMS that will be essential to gaining a QMS Certificate in the MDR era.
Your opportunity to hear more from John with other industry peers is coming up this month. Reserve your spot to attend the webinar for free.