EU Regulatory Roundup, November 2019: Big Changes For Medtech Regs Implementation
Executive Summary
With six months left to the full implementation of the EU’s Medical Devices Regulation, there are a couple of big shifts taking place in the way it is being applied. Following news of the Eudamed database two-year delay, confirmation looks imminent that many more products will avoid having to comply with the MDR by next May. But will this plan sufficiently alleviate implementation pressures?