The EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)
The EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR) took effect on 26 May 2017, and a transitional period of 5 years is in force till 26 May 2022. The IVDR replaces the current EU In Vitro Diagnostic Medical Device Directive (IVDD) (98/79/EC) to ensure a higher level of health and safety for making available and putting devices into service in the market, and sets new rules for applying the CE marking to IVDs. Being a regulation, it is not required to be transposed into national laws, ensuring consistent interpretation throughout the EU.
IVDR Challenges and opportunities
The EU IVDR will bring about several changes. Some (but not all) of its consequences include
- A new classification system based on risks
- New conformity assessment routes
- Enhanced transparency and traceability levels,
- New rules governing health institutions wanting to use lab developed tests
- Requirement for additional documentation and/or revision of the current documentation.
It has become imperative for all stakeholders to be prepared, and this will involve a considerable amount of planning, effort and possible investment.
BD Biosciences has launched an initiative to spread awareness about the IVDR through a comprehensive information campaign directed at our customers. In the coming months, we will bring out insightful content on what the IVDR entails and how we as a company and our customers will be impacted by it. Preparedness is key for the IVDR!
Visit the dedicated site of the BD Biosciences IVDR campaign here.