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EU Commission Proposes More Time for Compliance with In Vitro Diagnostics Regulation

Scientist's hand with blue gloves taking frozen clinical samples

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical devices with additional time to comply with the requirements of the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR).

Originally published in 2017, the EU’s IVDR established a new regulatory framework applicable to in vitro devices (IVDs). Requirements under the IVDR are scheduled to take effect in May 2025 for high-risk IVDs and May 2027 for lower-risk devices.

However, according to a press release issued in late January, the Commission is concerned that many IVDs currently on the market still do not comply with the new requirements, including a number of what it classifies as high-risk IVDs used to test for infections in blood and organs.

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Accordingly, the Commission has proposed extending deadlines for compliance with the IVDR requirements as follows:

  • For Class D devices, including high individual and public health risk devices such as HIV or hepatitis tests, a deadline of December 2027;
  • For Class C devices, including high individual and/or moderate public health risks devices such as cancer tests, a deadline of December 2028; and
  • For Class A and B devices, including lower-risk devices such as pregnancy tests and blood collection tubes, a deadline of December 2029.

According to the Commission’s press release, their proposal to extend the IVDR transition deadlines will now go to the EU Parliament and Council for their review and adoption.

Read the EU Commission’s press release detailing its proposed changes to the implementation dates of the IVDR.

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