Episode description
This is the audio from RQM+ Live! #50, recorded 10 March, 2022.
A "notified body application" for IVDR CE certification can feel like 510(k) submission to IVD manufacturers who are new to the notified body relationship. Notified bodies are quoting a range of < 1month to 6+ months review time based upon application quality. Per the notified bodies, the majority of applications have problems, so a 6+ month review time is currently the norm.
Errors and deficiencies are commonly found in the intended purpose, classification, code assignments, acceptability of product groupings, and verification and description of activities of suppliers, subcontractors, and manufacturing sites.
In this Live! show featuring former notified body representatives fresh out of their IVDR leadership roles, we'll discuss best practices for delivering accurate and compliant applications that will be reviewed efficiently, and accepted by the notified bodies.
Panelists:
- Heike Möhlig-Zuttermeister, Ph.D. – Vice President of IVD Intelligence & Innovation
- Carlos Galamba, MSc – Vice President of IVD Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Felicia Hosey, RAC – Principal Advisor
Questions:
2:35 -- Let's define the term notified body application and ask... why is it an important step of the process?
8:51 -- Is the application the same for all notified bodies?
11:39 -- When should manufacturers start the application process?
19:18 -- What are the key components that are part of the notified body application?
34:43 -- If we need a brand new device certification from a notified body we've never worked with before, the process starts first by contacting them on the website and then the application process starts... what does that look like? What kind of documentation is required when you think about the application process versus just contacting and shopping for a notified body?
39:47 -- If we're going to launch a novel or innovative IVD in Europe in 2025, when would we need to engage a notified body?
44:52 -- Let's talk about pricing... can we negotiate our pricing? What does this proposal really mean? What exactly are man-hours?
51:06 -- Any final lessons learned or best practices to share with everyone listening?