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EU Amending Regulation (EU) 2023/607 & IVDR: Sell-off period for in vitro diagnostic medical devices abolished!

IVD Amendment
Apr  6, 2023
4 minutes read

Since March 20, 2023, Regulation (EU) 2023/607 has been in force, which, among other things, aims to abolish the sell-by period for in vitro diagnostic medical devices. This important measure is intended to ensure that in vitro diagnostics can continue to be used safely and reliably in the future to ensure patient safety. In the following we will take a closer look at the already extended transition periods under Regulation (EU) 2022/112 and the significance of the elimination of the sell-off period for in vitro diagnostic medical devices.

Without in vitro diagnostic (IVD) devices, modern medicine would be much poorer and healthcare less effective. After all, they enable physicians and healthcare professionals to detect and monitor diseases with high precision and speed, ensuring targeted treatment.

To ensure reliable and safe use of in vitro diagnostic devices, Regulation (EU) 2017/746 (IVDR) provides the current regulatory basis for their placing on the market and putting into service in Europe.

However, the IVDR presents numerous challenges as it sets stricter requirements for conformity assessment and post-market surveillance of in vitro diagnostic devices compared to the previous directive.

To address these, Regulation (EU) 2022/112 of the European Parliament and of the Council was published last year.

(EU) 2022/112: New deadlines for the classification of IVDs

Regulation (EU) 2022/112 defines differentiated transition periods for in vitro diagnostic devices (IVDs), depending on the respective risk class of the device and the date of placing on the market. Specifically, devices that were placed on the market before May 26, 2022, without the involvement of a Notified Body, but now require such involvement under the new regulation, must meet certain deadlines before they can be marketed or put into service in the EU.

These are as follows:

  • Class D products must be adapted by May 26, 2025.
  • Class C products have until May 26, 2026 to be adapted.
  • Class B products, as well as Class A products that are distributed sterile, must be brought into compliance by May 26, 2027.

On the other hand, devices that were placed on the market before May 26, 2022, with a certificate issued by a Notified Body may still be placed on the market or put into service until May 26, 2025, according to the directive.

The extended transition periods provided by Regulation (EU) 2022/112 offer companies more time to classify and approve their products accordingly. As a result, companies can avoid bottlenecks in the certification of IVDs and better plan their product development. At the same time, they can ensure that their products meet the new requirements and can therefore continue to be used safely and reliably to ensure patient safety.

But with the removal of the sell-off date for in vitro diagnostics (IVDs) by Regulation (EU) 2023/607, the EU Commission is launching another significant change.

(EU) 2023/607: Sell-off deadline for IVDs finally cancelled!

Until now, companies that manufacture and distribute in vitro diagnostic devices (IVDs) were subject to strict requirements regarding the sell-off period. Products that were lawfully placed on the market before May 26, 2022, under the previous EU Directive on IVDs, or lawfully placed on the market after May 26, 2022, under paragraph 3, had to be sold off within a certain period. But since the adoption of Regulation (EU) 2023/607, this limitation now belongs to the past. Companies now have the possibility to make their products available on the market or put them into service without time restrictions. This significant measure is intended to ensure that IVDs can continue to be used safely and reliably in the future to ensure patient safety.

Our offer: Experienced support during implementation

Despite the already mandatory application of the IVDR, new implementing and delegated acts as well as guidance documents are still being published, which are of great importance for IVD manufacturers. In order to stay up to date, competent and reliable support is essential.

In this regard, we at TentaConsult Pharma & Med can assist you as an experienced partner.

With our expertise in the field of IVDR, we ensure efficient and individual implementation to help you achieve IVDR compliance as quickly as possible and ensure the marketability of your in vitro diagnostics.

Don't hesitate any longer and rely on us to future-proof your in-vitro diagnostics.

Contact us today!

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Anja Heinrich
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