In-vitro diagnostics (IVDs) are medical devices to be utilized in vitro to examine examples obtained from the human body to retrieve data about a physiological or pathological state, an inborn abnormality, or to determine safety and compatibility with a possible beneficiary, or to screen therapeutic measures.
The meaning of an IVD doesn’t include any products that their intended use is for general laboratory use and not fabricated, sold, or designed for use individually as an IVD.
In-vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) is the actual regulation that governs the market access of IVDs in Europe. In 2017, a new in-vitro diagnostics medical device regulation (IVDR EU 2017/746) was adopted, introducing more strict safety requirements for commercial authorization. The reform was urgently needed to protect patient safety and regulate novel products properly.
The IVDR came into force on 26 May 2017 and had five years of transition. Manufacturers and developers will need to use new ways to market, and suppliers will need to adapt existing IVDs to comply with new requirements.
One of the main improvements of the new regulation is that the classification of IVDs are done under “risk-based rules” and not under a pre-determined list of devices. The main characteristics of the new risk-based classification are:
- Class A Low personal risk, low public health risk
- Class B Moderate to low personal risk, low public health risk
- Class C High personal risk, moderate to low public health risk
- Class D High public health risk, high personal risk
This new classification is not only reshaping the groups of IVDs, but the requirements to get the CE Mark, especially those related to having approval from a Notified Body.
A study made by the national institute for public health and the environment of Netherlands (RIVM Letter report 2018-0082 A. van Drongelen et al.) showed that under the IVDD, currently, 7% of the registered IVDs require the involvement of a notified body. However, when the entries were classified according to the IVDR rules, 84% of IVDs would require a notified body involved in the certification.
Classification Rules Annex VIII
The new regulation provides a step-by-step set of rules where an IVD can be categorized depending on a set of the main characteristic that the device has.
One of the significant improvements in patient safety is that the IVDs that under IVDD didn’t fit in a specific rule-class were self-certified, now, under IVDR’s rule 6, they are notified body certified.
AKRN specializes in the IVDD 98/79/EC, and the new EU IVDR 2017/746. As part of our regulatory services, AKRN can assist with all requirements needed to achieve the CE mark under the new IVDR and perform a complete transition from IVDD to IVDR.
Subject Matter Expert
Maria Nyåkern, Ph.D. Founder & Executive Director LinkedIn