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.
Manufacturers of COVID-19 tests may now have longer to comply with the IVD Regulation. But those from third countries need to be aware of the deadlines and hurdles ahead and act now.
The text amending the IVD Regulation, taking the pressure of the entire sector, has now been officially published. But clarification is needed regarding timelines for compliance for in-house IVDs.