---
title: Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR
description: The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices.
---

[News & Insights - Aurevia ](https://www.aurevia.com/news)

# [Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR](https://www.aurevia.com/news/voting-complete-extension-of-mdr-transition-times-and-removal-of-sell-off-period-for-devices-from-mdr-and-ivdr)

 Written by [Aurevia](https://www.aurevia.com/news/author/aurevia) | 16 Feb 2023

**The EU Parliament has adopted the MDR amendment proposal, February 16th, and removed the sell-off date for both medical devices and in-vitro medical devices. The amendment will come in force upon publication in the official journal, which is expected in the coming weeks.**

The European Parliament has on February 16th adopted the [Commission proposal](https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf?utm_campaign=lv_nyhetsbrev&utm_medium=email&utm_source=newsletter) for bridging measures for certificates that expire pending MDR conformity assessment. The [transitional provisions](https://www.europarl.europa.eu/doceo/document/TA-9-2023-0052_EN.pdf) extends the transition time for certain medical devices under MDR 2017/745 Article 120(3) by risk class as following:

- 31 December 2027 – all class III, and class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors;
- 31 December 2028 – for class IIb other than above, class IIa devices, and class I devices placed on the market sterile, or having a measuring function, or are reusable surgical instrument;
- 26 May 2026 – for class III custom-made implantable devices.

The extension of transition time is combined with an extension of validity of certificates issued under MDD by amending MDR Article 120(2).

Conditions for extension:

- the devices continue to comply with the directives (MDD, AIMDD);
- devices have not undergone significant changes in design or intended purpose;
- the devices do not present an unacceptable risk to health or safety of patients, users, other persons, or other aspects of the protection of public health;
- the manufacturer has put in place a quality management system according to MDR no later than 26 May 2024;
- the manufacturer has lodged a formal application with a notified body no later than 26 May 2024, and have signed a written agreement no later than 26 September 2024.

Also, the sell-off date in Article 120(4) of MDR 2017/745 and the corresponding Article 110(4) of IVDR 2017/746 has been removed, enabling distribution of legacy products until stock is empty.

 

[View full post](https://www.aurevia.com/news/voting-complete-extension-of-mdr-transition-times-and-removal-of-sell-off-period-for-devices-from-mdr-and-ivdr)

```json
{
  "@context" : "http://schema.org",
  "@type" : "BlogPosting",
  "author" : {
    "@type" : "Person",
    "name" : "Aurevia"
  },
  "dateModified" : "2025-12-16T18:32:48.318Z",
  "datePublished" : "2023-02-16T23:00:00Z",
  "headline" : "Voting Complete – extension of MDR transition times and removal of sell-off period for devices from MDR and IVDR",
  "image" : {
    "@type" : "ImageObject",
    "height" : 720,
    "url" : "https://147054699.fs1.hubspotusercontent-eu1.net/hubfs/147054699/Imported_Blog_Media/Aurevia-web-news-insights-featured-Dec-16-2025-06-32-31-2261-PM.png",
    "width" : 1280
  },
  "mainEntityOfPage" : "https://www.aurevia.com/news/voting-complete-extension-of-mdr-transition-times-and-removal-of-sell-off-period-for-devices-from-mdr-and-ivdr",
  "publisher" : {
    "@type" : "Organization",
    "logo" : {
      "@type" : "ImageObject",
      "height" : 60,
      "url" : "/hs/hsstatic/content_shared_assets/static-1.4092/img/default-amp-logo.png",
      "width" : 60
    },
    "name" : "News"
  }
}
```