Are you a self-certified IVD manufacturer?
The new IVDR makes necessary for about 80% of IVD manufacturers with self-declared products to require some form of Notified Body involvement. Under the existing IVDD, approximately 80% of IVD manufacturers are self-certified and do not require Notified Body involvement.
The new IVDR comes with new classification rules which will make necessary about 80% of IVD manufacturers to require some form of Notified Body involvement, a four-fold increment from before.
This means that the majority of IVD manufacturers, who have never had to engage with a Notified Body, will now be required to have both their Quality Management Systems (QMS) and technical documentation audited by one for the first time.
With the new Regulation, the definition of ‘in vitro diagnostic medical device‘ has been expanded and IVDs are classified into four risk categories, in line with the categorisation that already exists for other medical devices. IVDs will no longer be subjected to the list-based system found in the IVDD, but they are classified into the risk classes developed by the Global Harmonization Task Force (GHTF).
The IVDs are classified into risk classes A (low risk) to D (high public and high patient risk) after passing through seven classification rules. This risk classification will require increased involvement of a Notified Body for the approval of all but Class A devices.
LRQA has put together a guide to help manufacturers with self-declared products understand what the changes mean for their organisations.