Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein) | Oireachtas source

I welcome our guests. The briefing note we have received refers to proposals designed to ensure all medical devices are safe for patients and restore public confidence in the European medical devices regulatory system. It is fair to state said confidence has been significantly dented and that it is important that it be restored. The debacles involving DePuy hip implants and PIP breast implants have had an impact on Irish people and I have no doubt that this impact has been replicated - it may even be more pronounced - in other jurisdictions.

The briefing note sets out several bullet points under the briefing summary. One I highlighted is that of more powers and obligations for notified bodies to ensure thorough testing and regular checks on manufacturers, including unannounced factory inspections and sample testing. That would most certainly address the issue of the PIP implants where wholly and totally inappropriate material was being used, which would have been established if such unannounced factory inspections were taking place regularly and we had a robust examination and testing of the quality of materials and their suitability for in vitrouse by humankind.

Mr. Pat O'Mahony might update us on where things are with regard to both of these matters. Can we have some assurance as to the steps that are being taken collegially across the European Union? These directives are part of the response I expect, yet as Mr. Paul Barron indicated, the Department of Health has concerns about the original drafting and some other member states still have concerns about it. In his address to the committee, Mr. Paul Barron mentioned that member states had concerns regarding many of the proposed measures. Will he elaborate on which member states they are? Clearly, we must number among them. He also indicated in the course of his opening statement that some of these concerns were shared and that he believes the Department's concerns have been ameliorated by amendments that have been adopted by the Commission. The phrase he used is that they "went a long way towards resolving our main concerns". Will he elaborate on what concerns remain? He did not suggest that they were all addressed comprehensively. Are they of such minor nature that he considers we should have no issue with the adoption of directives at this point and that we are in a position to proceed positively with the proposals?

Mr. Barron made the point that the ENVI committee "has voted in favour of pre-market authorisation for high risk medical devices via a centralised EU structure of notified bodies approved by the European Medicines Agency". He indicated that the Council does not have a position on this issue as yet. It is ancillary, I guess, to the substantive issue being addressed, but what of the Department of Health's view on that specific area? I would be grateful if he could give us a further insight into that.