The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Entering into force on May 25, 2017 marking the start of a five-year transition period for manufacturers and economic operators, the IVDR replaces the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC.

Manufacturers wishing to apply to a notified body for a conformity assessment of their IVD medical device have until the Date of Application of the IVDR in May 2022 to update their Technical Documentation to meet the requirements and comply with the new, more stringent Regulation.

The major areas of change in the IVDR include:

• Rule-based classification system
• Requirements for clinical evidence and post-market performance follow-up
• Increased traceability of devices (UDI)

As a manufacturer of in-vitro diagnostic devices, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market.

European Union

In Vitro Diagnostic Regulation (IVDR) 2017/746

Further Industry and Regulatory Guidance is also available.

BSI The Netherlands is a Notified Body (2797) achieving full-scope designation under IVDR and MDR. We are also a full-scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your IVD device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your product to the market.

For more information visit our CE marking and UKCA marking dedicated webpages.