FAQs: In Vitro Diagnostic Medical Device Regulation

By Matthew Nowland and Charles Chrisawn

On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). Products that are not already approved (carry the CE Mark) must be registered certified following the new requirements starting May 26, 2022. The new rule reclassified some products and established four categories based on importance to patients’ health and/or risk. In addition, they created a schedule for products that are already certified to be re-certified/updated per the new regulation as follows:

All devices will need to be divided into classes, A, B, C, or D, taking into account their purpose intended by the manufacturer and inherent risks​.

• Class A – low to moderate risk (General Controls)​
• Class B – moderate to high risk (Special Controls)​
• Class C – high-risk (Pre-market Approval)​
• Class D- Transmissible Disease, Blood screening, High risk disease, High-risk Blood groups​ (Pre-Market Approval)

The new In Vitro Diagnostic Medical Devices Regulation can be found here (European Parliament website).

Discover FAQs regarding the expected changes below.