With the new EU IVD Regulation 2017/746 entering into force on 26th May 2017, in vitro diagnostic medical devices will no longer be classified with a list-based approach, but instead (and similarly to the Medical Devices Directive 93/42/EEC) with a risk-based approach.
As explained in one of our previous news articles, this is one of the reasons why the gap between the Law and Innovation that was often preventing manufacturers from placing their devices on the EU market is finally going to end.
New definitions
With the IVDR, new devices are now covered and assessed on their own. The expanded definition of the IVDR now also includes the following devices:
- Companion Diagnostic: a device which is essential for the safe and effective use of a corresponding medicinal product to:
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk for serious adverse reactions as a result of treatment with the corresponding medicinal product;
2. Device for ‘near-patient testing’: any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
New paths
New classifications will create new challenges – should you wish to enter the EU Market, please do not hesitate to contact us. Having nearly 30 years of experience with EU Regulations, we will gladly answer any questions you may have and assist you throughout the required procedures.
Guilherme Ferrugento