MDCG 2020-16 Guidance on Classification Rules for IVDR
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Article 47 of the IVDR EU 2017/746 defines four new risk classes (A, B, C, D) considering the intended purpose of the devices. As an IVD manufacturer you should review the 7 classification rules given on Annex VIII of the IVDR and define the risk class of your device.
Compared to 98/79/EC IVD Directive (IVDD) the classification of the devices is one of the most important changes which manufacturers must comply during IVDR transition. The rigid classification system of IVDD now becomes a flexible IVDR Risk Classification system which enables room for new devices and technology developments.
In the good old days, most the IVD devices could be marketed with a self-declaration without a Notified Body intervention. Only List A, List B and self-test devices were required to go through a conformity assessment procedure via a Notified Body.
IVDR Risk Classification
The IVDR is now changing the game by increasing the Notified Body intervention during the conformity assessment procedures. Therefore, many manufacturers will go through a certification process for the first time. Considering the low number of available Notified Bodies and transition timelines, this seems to be real challenge for many mid-sized manufacturers.
The MDCG 2020-16 Guidance brings clarification to the IVDR Risk Classification rules listed on Annex VIII. The guidance document includes rationale and examples (non-exhaustive) for each IVDR Risk Classification rule. Apart from the examples the initial paragraphs of the guidance document gives a very good summary about the principles of classification.