Draft Texts of New Medical Devices and In-vitro Diagnostics (IVD) Regulations Released

As previously reported, on 25 May 2016, the European Parliament and the Council agreed on the final texts of the new Medical Devices and In-vitro Diagnostics (IVD) Regulations. The Parliament and Council are still negotiating certain aspects in relation to reprocessing with the European Commission, however, the draft texts have been released and signed off by the two committees.

Please find copies of the compromise texts below:

MD – Consolidated Negotiated Text

IVD – Consolidated Negotiated Text

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Published on 16. June 2016 in News EU