Tabled amendments to draft EU regulations on in vitro diagnostic medical devices (IVDDR)
This note supplements the PHG Foundation response circulated in November 2012 and our consultation response to the MHRA consultation earlier this year.
A number of European Union Committees have submitted draft reports proposing amendments to the draft IVD and Medical Devices Regulations published last September.
As well as publishing reports, each of these committees (Environment, Public Health and Food Safety (ENVI); Internal Market and Consumer Protection (IMCO); and Employment and Social Affairs) have tabled supplementary amendments for discussion. Taken together, these amendments have substantive implications which we address below as an aid to stakeholders and to inform decision making and the legislative process over the next few months.