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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.
Latest From Europe, Policy & Regulation
Manufacturers who have not managed to transfer their certificates from a UK notified body prior to Brexit, or who have not obtained certificates under the EU Medical Device or IVD Regulations in time, can not expect to receive a sympathetic hearing from the EU Commission. In an interview with Medtech Insight, Lawyer Alison Dennis examines options for medtech firms.
With new legislation imminent in Belgium on distribution rules for medical devices, how much more open is the market going to become, and what must companies be aware of? Two experts discuss.
NHS England's IVD and pathology sector is undergoing a major reorganization to make it fit for the future, responsive to growing demand and more patient-friendly. The plans are helping to change mindsets locally about how IVDs and pathology services should be delivered, according to speakers at a recent summit.
In line with what the European Commission has been saying about the structures starting to fall into place under the Medical Device and IVD Regulations, its Medical Device Coordination Group is taking shape.
Elżbieta Bieńkowska, a European Commissioner, is "realistic and confident" when it comes to the implementation of the new EU medtech regulations. She says everything is going to plan. But that is not what members of the European Parliament are hearing.
BSI, which claims to be the largest medical device notified body in the EU, is awaiting news of its designation against the new European regulations and the current European directives in the EU27. At least one of those could be the subject of a designation recently signaled by the European Commission for next month.
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