Category - MDR

medicaldeviceslegal

Product liability for devices under MDR and IVDR

With the MDR and IVDR nearing completion in the trilogue negotiations the final outline of these two statutes become more and more clear. It looks now like the regulations will be agreed upon during this Presidency, which means they could be published in the Official Journal and enter into force this autumn. I’m referring to […]

medicaldeviceslegal

Update on MDR/IVDR trilogue

The trilogue has been quietly progressing, with a view to being concluded for this Presidency at the EPSCO meeting of the Council on 8 December after a final trilogue meeting planned on 3 December. That is, for this Presidency (the Luxemburg one). If the  Commission, Parliament and Commission do not manage to reach consensus on everything, the […]

medicaldeviceslegal

Update! White paper on MDR / IVDR updated

In March 2014 Gert Bos (Head of Regulatory and Clinical Affairs at notified body BSI) and I wrote a white paper on the new EU medical devices and IVD regulations in the legislative procedure. It was well received and as the legislative procedure for the regulations progressed there has been an increasing demand for update of the […]