8 New Elements Of The IVDR — And How To Change Your Approach

By Nach Davé

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean?

Many of our sponsors have been approaching us with questions, such as:

• What aspects of the IVDR apply to my business?
• What types of data generation need to be in place?
• Does any grace period apply, given the December progressive rollout update?
• Who can I work with to ensure there are no gaps in my understanding of compliance?

The answers, tiny details that could make or break in vitro diagnostic (IVD) approval, lie buried within an extensive document. Fortunately, we at Premier have done the digging — so you don’t have to.