What is the “sell off” provision?

The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which IVDD-compliant devices, already placed on the market, can be provided by (i.e.) Distributors.

According to the new transitory provisions, IVD Devices lawfully placed on the market under the IVDD directive before 26th May 2022, can still be put into service until 26th May 2025.

On the other hand, IVD Devices lawfully placed on the market as from 26th May 2022, can continue to be placed on the market or put into service until the following dates:

  • 26th May 2026 for class D IVD devices
  • 26th May 2027 for class C IVD devices
  • 26th May 2028 for class B and class A sterile IVD devices.

Discover the strategic-regulatory consultancy services Thema

Are you a Manufacturer of in vitro Diagnostic Medical Devices?

Fill out the form!

You will receive our White Paper directly on your inbox: a valuable help to understand the necessary actions to be taken to adapt to the IVDR and to be able to market your IVDR devices throughout Europe.

Name and Surname
Company
Role
Email
Consent to processing of data
in accordance with D. Lgs. 196/2003 adapted to the GDPR 679/16 EU by the D. Lgs. 101/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l
Information concerning the processing of personal data