The “sell off” provision under the MDR and IVDR

The EU Competent Authorities for Medical Devices (CAMD) have recently released their FAQs to provide guidance on certain specific aspects concerning MDR/IVDR transition-related provisions.

One of the elements that was covered by the CAMD FAQs is the so called “sell offprovision (Art. 120 par. 4 MDR & Art. 110 par. 4 IVDR). The purpose of such provision is to limit the time in which compliant devices already placed on the market prior to the date of application (DoA) of the new MDR & IVDR may be made available for sale, for instance by a distributor. Let’s see in practice what these provisions establish for medical devices and in vitro diagnostics devices.

Art. 120 par. 4 MDR

AIMDD/MDD[1] compliant devices placed on the market before 26 May 2020 or devices with certificates issued in accordance with AIMDD/MDD placed on the market after the DoA[2] with no significant change in design and intended purpose can be made available until 27 May 2025. After the aforementioned date, these devices will not be marketable anymore, even if they are already in the supply chain but have not yet reached the final user.

Art. 110 par. 4 IVDR

IVDD[3] compliant devices placed on the market before 26 May 2022 (DoA) or devices with certificates issued in accordance with Directive 98/79/EC with no significant change in design and intended purpose placed on the market after the DoA[4], can be made available until 27 May 2025. After this date, similarly to the case of the MDR, IVDD compliant devices will not be marketable anymore even if already in the supply chain.

Contact Us

If you wish to receive more regulatory updates or clarifications concerning the implementation of the MDR and IVDR, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any questions you may have and will gladly assist you in safeguarding your products’ compliance.

Alessandro Polimeno

[1] Directive 90/385/EEC or Directive 93/42/EEC

[2] Article 120 par. 3 of MDR

[3] Directive 98/79/EC

[4] Article 110 par. 3 of IVDR

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