Dáil Éireann Debate, Wednesday - 1 February 2023
62. Deputy John Paul Phelan asked the Minister for Enterprise, Trade and Employment the number of staff at the National Standards Authority of Ireland with responsibility for approval of medical devices. [5062/23]
View answer63. Deputy John Paul Phelan asked the Minister for Enterprise, Trade and Employment the average length of time from application submission to final approval of medical devices at the National Standards Authority of Ireland. [5063/23]
View answer64. Deputy John Paul Phelan asked the Minister for Enterprise, Trade and Employment the measures he is taking to reduce approval times at the National Standards Authority of Ireland for medical devices. [5064/23]
View answerI propose to take Questions Nos. 62, 63 and 64 together.
The National Standards Authority of Ireland (NSAI) is an independent agency, under the aegis of my Department. As part of its remit, NSAI carries out a range of operational functions, some of which are in areas which fall within the lead policy responsibility of other Departments. In this context, NSAI carries out activities in relation to Medical Devices, which is an area within the lead policy responsibility of the Department of Health.
I am aware from my colleague Minister Stephen Donnelly T.D. that while lack of capacity of notified bodies throughout the EU and lack of preparedness of manufacturers have posed challenges for existing notified bodies, plans are in train at European level to alleviate the current disruption in the supply of medical devices to patients.
NSAI medical devices division comprises a total of 70 personnel. Approval application times for medical devices can currently range from 3-6 months, for lower classification reviews, where no additional issues arise, up to 18–24 month timelines for certification in more detailed cases. However, significant reductions can be achieved depending on the level of complexity of the submissions, the classification of the devices, and the quality and comprehensiveness of the applications.
I welcome the recent Commission proposal to the Council and to the European Parliament for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. This proposal, which is aimed at allowing manufacturers and notified bodies additional time to transition from the previous applicable rules to the requirements of the new Regulations, is a positive step to clear backlogs throughout the system.
NSAI actively contributes to discussions at European level on finding solutions to the current circumstances in the sector.
