Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

In the wake of MDR, the topic of notified bodies has received quite a bit of negative attention...and for good reason.

There’s been a substantial reduction of notified bodies designated under MDD to MDR…

Originally 126 to now just 23 notified bodies currently designated under MDR, to be exact.

As a result, the EU go-to-market journey is fraught with roadblocks. It’s no wonder that increasing contention exists between notified bodies and manufacturers.

In this free in-depth webinar presented by regulatory expert Michelle Lott, president of Lean RAQA, participants will get the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and challenges they are facing during this transition period.

Register now to unlock the powerful knowledge Michelle will share about her lessons learned working alongside notified bodies and manufacturers and the do’s and don'ts every manufacturer must know if marketing a medical device in the EU market.

Specifically, this webinar will cover:

• Provide real life examples from products going through this transition period

• Identify areas where industry is consistently making mistakes from the Notified Body perspective

• Review appeals pathways or other options if opposing opinions arise

• Provide valuable insight on how industry can align with the expectations of Notified Bodies under MDR

Who should attend?

• Any industry representative that is either in the EU now or intends to pursue commercialization in the EU market

• Medical Device Executives

• Regulatory Affairs Professionals and Management

• Quality Professionals and Management

• Clinical Affairs Professionals and Management

• R&D Engineers and Management

• Learning level: Intermediate