EU Regulatory Roundup, October 2018: Regs 'On Track,' First NB Designations On Way, While UK Prepares For No-Deal Brexit
The European Commission has been much more vocal this month. Its message is upbeat. Despite what industry is saying about delays, logjams and products being forced off the market, it claims to be "on track" for timely implementation of the EU's new Medical Device and IVD Regulations. That and more, in top EU regulation stories from October.
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With just over three weeks to provide input on the UK's proposed regulatory response to the prospect of a no-deal Brexit, Medtech Insight unravels key messages from the four documents issued by the Medicines and Healthcare products Regulatory Agency (MHRA), condensing 127 pages into the main points to aid industry in providing feedback. There's no time to waste for those wishing to influence the outcome.
The European Commission is optimistic that work on standards for the new EU medtech regulations will begin as soon as May. After previous setbacks, the medtech sector is pinning it hopes on the EU standards bodies, CEN and Cenelec, accepting the Commission’s latest proposal
The medtech sector has reached the point of exasperation over the European Commission’s handling of virtual audits under the MDR and IVDR. Advantages gained by having a delay in the MDR date of application could be all but lost.