Gerald Nash (Louth, Labour)
Link to this: Individually | In context | Oireachtas source

343. To ask the Minister for Enterprise, Trade and Employment the reasons the National Standards Authority of Ireland (NSAI) has had to pause the certification of in-vitro medical devices and products; what actions have been taken by the NSAI to address the reasons for this pause; when the process will be permitted to commence again; if he is concerned that the pause will impact on Ireland's reputation as a centre for the med-tech sector; and if he will make a statement on the matter. [9410/25]

Peter Burke (Longford-Westmeath, Fine Gael)
Link to this: Individually | In context | Oireachtas source

Minister for Enterprise, Trade and Employment (Peter Burke):

The National Standards Authority of Ireland (NSAI) is an agency of the Department of Enterprise, Trade and Employment. In addition to its functions in legal metrology and standards, the NSAI also offers certification services for In Vitro Devices, under EU’s In Vitro Diagnostic Regulations (2017/746). Under the Regulations, Heath Products Regulatory Authority (HPRA) is appointed as the supervisory authority for certification. NSAI has achieved designation as a notified body under the regulation and is subject to regular audits by HPRA.

HPRA’s specific concerns relate to NSAI’s overall operational ability in relation to IVDR decision making. While NSAI had taken significant steps to address procedural shortcomings, and extensive recruitment for suitably qualified staff is ongoing, not all matters had been fully resolved to HPRA's satisfaction. This culminated in HPRA's decision in December 2024 to temporarily suspend NSAI’s IVDR designation for three months, i.e. until 17th March 2025.

During the suspension period, NSAI has worked hard to introduce more robust processes to address HPRA’s concerns. The Department is happy with NSAI’s progress in addressing the challenges and is hopeful that the suspension will be lifted by the given date.

It is important to note that IVDR certification is an operational matter for NSAI's executive and its Board to address. NSAI's IVDR designation is not a statutory function. In addition, I understand that no enterprise has been adversely affected by the suspension.