Do we need an Authorized Representative if we are marketing a self-certified IVD?
Yes. You must select an AR if you do not have a place of business in Europe, regardless of the category or classification of your IVD. Read more about Emergo Authorized Representation.
Are Notified Body audits required for all types of IVDs?
Unless you are marketing a self-certified IVD device, you will need the intervention of a Notified Body and a Notified Body CE Certificate. In fact, most IVD manufacturers will need to engage Notified Bodies as part of the conformity assessment procedures under Europe's new In Vitro Diagnostic Regulation (IVDR).
How will IVDs be classified under the new IVDR?
Under the IVDR, there will be four risk-based classes — A, B, C, and D. Most "self-testing" IVDs will fall under Class C; many IVDs currently classified as self-certified will be classified as higher risk.
How will the IVDR affect current CE Marking certification for our product?
The IVDR will come into force in late 2021 or early 2022. CE Mark certificates issued before final implementation of the IVDR will remain valid for a maximum of two years following final implementation of the new regulations.