Mr. Michael Scannell:

The Italian Presidency made huge efforts to secure agreement on the issue of medical devices before the fall of the European Parliament. Unfortunately, as it did not succeed, essentially we are in a new political environment. The Parliament has adopted its position on the proposals, but the Council has yet to decide. It is a difficult issue which involves the approval of medical devices at member state level. Under the new proposals, we propose a hybrid model. Approval would rest with individual member states, but in the case of more sensitive medical devices, there would be opportunities to review the position at European level. It is a huge industry which is hugely important. First and foremost, everybody agrees that medical devices must be safe. Secondary to this is the huge economic significance of the sector, of which Ireland is well aware, as it has a huge medical devices sector. It has a well functioning medical products regulatory agency which is world renowned and making an important input.

It is important to highlight the fact that we are not doing nothing while the legislation is being discussed. In parallel with the legislative procedures, we have put in place a range of measures to strengthen national procedures. A so-called joint action plan was agreed between the Commission and member states in recognition of the fact that we could not simply sit and wait for the new legislation to take effect. We must do something in the interim. For example, we now carry out audits in all member states to review the performance of the notified bodies referred to by the Commissioner to see that they are working to the appropriate standards. We have identified a good number of problems that are being pursued with member states.