Removal of 'Sell-off Date' as One of the Major Benefits From EU MDR Transition Extension
Removal of “sell-off date” can be considered as one of the benefits of EU MDR Transition Extension.
To Elaborate More on This Benefit, Let us Just Understand What Is Sell-Off Date?
Sell-Off Date means the last day of the Sell-Off Period, whether the Sell-Off Period expires or is terminated. After this period the device needs to be withdrawn/disposed off from the market and cannot be made available to the end user.
When EU MDR came into force, the “sell-off” provision was given for the devices placed on the market (e.g., delivered to a European distributor) of which MDD DoC and/or MDD EC certificate was going to expire before the May 26, 2021. This “sell-off” provision established the duration within which the device can continue to be made available on the market, which was May 26, 2025.
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What Was the Provision of “Sell-Off” (Art. 120 Para 4 MDR) Before EU MDR Transition Enforcement?
Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. They shall however become void at the latest on 27 May 2024.
It is possible to sell the devices covered by CE certificates issued in accordance with Directives 90/385/EEC and 93/42/EEC until the end of the validity period of the certificates. This is valid until 27 May 2024, after which it is mandatory to have on the market devices covered by certificates issued under the EU MDR or IVDR.”
Article 120 was intended to limit the time during which legacy devices (with valid MDD Certificate) which are already been placed on the market or available with the distributor. Article 120 intimated, May 27, 2025, as a deadline for these devices to be available in market. Even if these devices have not reached to final user/distributor and were in transit i.e. transport/supply chain by this date, they were not considered “marketable” anymore. It was advised to withdraw such devices from market before reaching to final user.
What Is Changed With EU MDR Transition Extension?
EU MDR transition extension has removed/deleted the “sell-off date” given by Article 120 for placing or making the legacy devices (with valid MDD certificate) available in market. With this provision, legacy devices which are already placed in market before or after May 26, 2021 can continue to be made available in market without any deadline but with appropriate consideration of shelf life or expiry date.
The removal/deletion of the “sell-off date” with effect from EU MDR Transition extension is aimed to prevent unnecessary disposal of safe and efficient devices and ensure its availability for patient’s and healthcare system’s need.
With the provision of this removal of “sell-off date” (previously May 27, 2025), medical devices placed on the market before the respective end of the transition period could be made further available on the market without a legal time restriction. This will help medical device manufacturer’s by preventing unnecessary disposal of already stocked medical devices.
However, to avail the benefits of EU MDR Transition Extension, medical device manufacturer should consider doing two important tasks before May 26, 2024 which are;
- Sign a contract with Notified body for MDR Conformity Assessment
- Implement EU MDR compliant Quality Management System.
How Operon Strategist Will Consult You?
We at Operon Strategist can help you to avail the benefits of EU MDR Transition Extension by guiding and supporting you for appropriate documentation whether it be complying for transition requirements, applying for transition extension as well as getting prepared for EU MDR certifications for your Medical Devices. Contact us for medical device regulatory information.
Medical Device Regulatory Professional with overall experience in Regulatory, Quality and Product development domain for Medical device, Drug-device and Pharmaceuticals for relevant regulations of EU, USFDA, UK, SFDA etc. PhD in Pharmaceutical Technology from SNDT University, Mumbai.
