News

7.12.2023 Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices

The designated EURLs together cover the following categories of class D IVDs:

  • Hepatitis and retroviruses
  • Herpesviruses
  • Bacterial agents
  • Respiratory viruses that cause life-threatening diseases

EURLs verify the performance of class D devices and compliance with common specifications and they perform batch testing of class D devices in response to requests by notified bodies. 

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https://health.ec.europa.eu/latest-updates/designation-eu-reference-laboratories-high-risk-vitro-diagnostic-medical-devices-2023-12-06_en

31.10.2023

Sertio has been designated as a notified body under EU IVDR!

We are grateful and appreciative to share that conformity assessment service under IVDR is now available from us.

Our notified body number is 3018.

Sertio is based in Finland, serving customers globally.

We warmly welcome you as our customer.

2.9.2023 

Class D device manufacturer, kindly note:

Only 18 months to go until IVDR compliance is mandatory!

Typical certification process takes 12-18 months. Timeline based on notified body survey.

We strongly advise to contact a notified body and start conformity assessment as soon as possible.

20.3.2023 

Regulation amendment 2023/607 changes transitional provisions

Sell off provision for IVD devices have been removed.

Devices with valid shelf life can be further delivered to clinical labroatories even after end of transition timeline as IVDD compliant.

30.1.2023 

MDCG 2023-1 Guidance for the health institutions published

MDCG 2023-1 Guidance for the health institutions exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 provides guidance for clinical laboratories on how to interpret IVDR requirements.

30.5.2023 

MDCG Guidance on SSP published

MDCG 2022-9 Summary of safety and performance template has been published. Follow the harmonized template format and prevent extra work.

30.5.2022 

MDCG 2022-6 Guidance on significant changes to IVD devices published

MDCG guidance about significant changes to legacy IVD devices regarding the transitional provision under Article 110(3) of the IVDR published. Good to read to be aware of what kind of changes are allowed during transitional period to continue to places on the market as IVDD compliant device. On the other hand, useful to read what kind of change is triggering a necessity for the device to be in compliance with IVDR.

26.1.2022 

IVDR transitional timelines

By the date below, devices need to be IVDR compliant

26.5.2022

  • All new IVD devices, in other words any device for which EU DoC has not been signed before 26 May 2022.
  • Any device to which significant changes have been made after 26 May 2022
  • All class A devices

26.5.2025

  • Class D devices
  • Devices with IVDD certificate

26.5.2026

  • Class C devices

26.5.2027

  • Class B devices
  • Class A sterile devices