Users and manufacturers of in vitro diagnostic devices ("IVDs") can breathe a little easier after the European Commission announced last week that the transitional periods for the In Vitro Diagnostic Medical Devices Regulation 2017/746 ("IVDR") will be extended in response to the challenges of the COVID-19 pandemic. We have published a full analysis of the proposal at Bristows' On the Pulse site.
The proposal will amend the IVDR transitional provisions to give devices which have undergone conformity assessment before 26 May 2022 a little more time to remain on the market after the application date. It is important to note the contrast between this extension and last year's extension of the MDR, which actually prolonged the Date of Application for the legislation.
We should also note that the proposal provides some statistics on page 7 which should be taken with a pinch of salt - the figure of 24,000 IVDs on the market which will need the involvement of a notified body seems smaller than might be expected under the more demanding regime introduced by the IVDR. In order to supplement the statistics provided by the Commission in the proposal, we have prepared the table below to also show the proportions of devices requiring notified body conformity assessment which fall into each risk class.
|Class||Approximate Number||% of IVDs on the market||% of IVDs requiring notified body involvement|
C and D classes will require the most stringent assessment by notified bodies and also have the shortest extension to their transition periods. Although they do form a minority of devices needing notified involvement body, it may still be a challenge for some manufacturers to meet the new deadlines if notified body capacity does not expand.
Without any legislative action, there is a risk of significant disruption in the supply of various essential in vitro diagnostic medical devices on the market, affecting the diagnosis of patients and their access to relevant health care. Hence today's proposal to ensure a progressive roll-out of the IVDR.