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IVDR instruction

The Regulation on In Vitro Diagnostic Medical Devices (IVDR) (2017/746) was approved on 5 April 2017, published in the EU Gazette on 5 May 2017, and came into force on 26 May 2017. It replaces the Directive on In Vitro Diagnostic Medical Devices (IVDD) (98/79 / EC) and enters a transitional period of 5 years. IVD manufacturers whose products are sold in the European Union should note that all in vitro diagnostic devices must meet IVDR requirements by 26 May 2022. IVD manufacturers need to update their technical documentation and processes during the transition period to meet the IVDR requirements of the new regulations.

Difference between IVDR and IVDD

IVDR differs in a number of respects from the current EU directive on in vitro diagnostic medical devices. The most significant changes in the proposed specification include:

1. Expand the product range;

2. Reclassification of devices;

3. Determine the "compliance principal";

4, improve the degree of participation of announcement institutions;

5. Implementation of unique device identification;

6. Stricter requirements on technical documentation and clinical evidence;

7, the announcement of the body's review is more stringent;

8. There is no "not subject to new regulations" rule.

IVDR instruction

Difference between IVDR and IVDD

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