In Vitro Diagnostic Regulations (IVDR) Training Course

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is a European Union regulation that governs the manufacture, distribution, and use of in vitro diagnostic medical devices (IVDs) within the EU. The IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and imposes more stringent requirements on IVD manufacturers and other stakeholders. If you work for any of the following organisations, you may need a good understanding of the regulation: in vitro diagnostic manufacturers, importers and distributors, healthcare institutions and laboratories, regulatory authorities, notified bodies, and trade associations and professional organisations.

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is specific to the European Union. Its impact can however extend beyond EU borders. For example, regulatory requirements in major markets such as the EU can influence developments and changes in standards in other regions.  The regulation can also affect players in the supply chain who themselves operate outside the EU but supply to organisations who do wish to market into the EU zone.

Yes. The IVDR was published in May 2017 and became applicable in May 2022, replacing the previous In Vitro Diagnostic Directive (IVDD).

During the transition period, manufacturers of in vitro diagnostic medical devices were given time to ensure compliance with the new IVDR requirements. The transition period can vary, but for most IVDs the transition period is five years from the date of application of the IVDR, which meant until May 2022. However, high-risk devices (Class D) and self-testing devices (Class B) have slightly different transition periods. Overall though, most manufacturers should be implementing the requirement or risk losing access to the EU market.

Bywater offers a wide range of complementary training courses around standards for medical devices, including:

• introduction to and auditor training for ISO 13485
• risk analysis
• introduction to ISO 15189 and auditor training for medical laboratories
• medical devices regulation (MDR)
• quality system regulations
• BS EN 62366 usability engineering

We offer a range of venue options to suit your requirements:

• scheduled training in our global Virtual Classroom
• in-company training at a venue and date of your choice

If you would like to discuss in-company training for your organisation, please contact our training team on 0333 123 9001 or email contact@bywater.co.uk to discuss your requirements.