New MD and IVD Regulations: Implications of Implementation

As Director of Devices for the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK, John Wilkinson helped to strategize and develop the medical devices and combination products sessions delivered at our DIA EuroMeeting 2017. As the European Parliament approved the new MDR (medical device regulation) and IVDR (in vitro diagnostics regulation) on 5 April 2017, these sessions were of particular importance. “We have seen the final text and we should see that translated into formal legislation at the end of May or early June. Although there are transition periods for the medical device regulation of three years, and for the IVD regulation it’s five years, some of the provisions start coming into force pretty much immediately – particularly in the market surveillance area,” Mr. Wilkinson explains in this Global Forum podcast. “Products are just getting so much more sophisticated, complex and invasive. So, therefore, the risk profile of products that are out there is increasing, and that demands a higher level of scrutiny.” To learn more, attend our DIA Workshop on Benefit-Risk Strategy, or our 11th Annual Forum for Qualified Persons in Pharmacovigilance, in Europe.