IVDR | Advena Ltd

MDCG 2025-5: Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746

27 June 2025 by Sam Attard

The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use … Read more

New Notified Body has been Designated Under IVDR

2 June 2025 by Sam Attard

There has been a new notified body that has been designated under the IVDR. The notified body is from Norway. The details of this notified bodies can be seen below: More information about this notified body can be found using the following link

COMMISSION IMPLEMENTING DECISION (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices

30 April 2025 by Sam Attard

Two new standards have been harmonised with the IVDR. Both standards are related to sterilization. The Implementing Decision can be accessed using the following link

Three New Notified Bodies have been Designated Under IVDR

30 April 2025 by Sam Attard

There has been a total of 3 new notified bodies that have been designated under the IVDR. The notified bodies are from Belgium, Spain and Italy respectively. The details of these notified bodies can be seen below: These new additions bring the total number of notified bodies to 16. More information about these notified bodies … Read more

Important Deadline for IVD Manufacturers

30 April 202530 April 2025 by Sam Attard

Manufacturers of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR) must be aware of a fast-approaching regulatory milestone. In accordance with (EU) 2024/1860, in order to benefit from the extended IVDR transition periods, manufacturers must satisfy a number of criteria, two of which will be due at the end of May. These … Read more

UPDATE: MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

1 April 2025 by Sam Attard

The guidance document MDCG 2020-16 has been recently updated. To offer some background to this guidance document, originally published in 2020, this guidance document provides clarification on the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR), focusing on Annex VIII classification rules. It applies to diagnostic services performed on EU … Read more

Latest Consolidated Version of IVDR Published

3 February 2025 by Sam Attard

The Latest version of the IVDR has been published in HTML format. The .pdf version is expected to be released in the near future. To access the latest consolidated version of the IVDR, click on the following link

EU Publishes New Harmonised Standards for MDR and IVDR

29 October 2024 by Sam Attard

To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU … Read more

MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices

24 October 2024 by Sam Attard

The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD. For a product to qualify as an IVD or … Read more

UPDATE: MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

27 September 2024 by Sam Attard

The guidance document MDCG 2021-4 has been updated. For context, under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers of class D in vitro diagnostic medical devices (IVDs) are required to submit their applications to a notified body as part of the conformity assessment process. Additionally, under certain conditions, specific elements of … Read more

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