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The race is on for companies to be among the first to CE mark their devices under the new EU regulations. Much will depend on which notified bodies are designated first; and national competent authorities play a key role.
Latest From Europe, Policy & Regulation
As the date that EU notified bodies can submit for designation under the new regulations rapidly approaches, can EU designating authorities audit notified bodies against the MDR and IVDR at the same time to improve efficiency? And can notified bodies audit against the legacy directives alongside the regulations to minimize worst-case logjams?
In the run-up to next Monday’s vote on the European Medicines Agency’s future home, political horse-trading and vote-swapping behind the scenes makes it difficult to predict which EU city will win the prized agency.
As medtech grapples with the overwhelmingly complex implementation of the EU's new Medical Device and IVD REgulations, one legal pioneer, Oxford's Christopher Hodges, says it's time to think differently.
It is nearly six months since the EU's Medical Device and IVD Regulations entered into force. In 10 days' time, on Nov. 26, notified bodies can apply to be designated under the new rules. More are ready than expected. Can the European Commission cope?
Germany's medtech industry is yet to find out who will hold the political reins for health care and the other ministerial portfolios that influence the market access and innovation support mechanisms for medtech products. Meanwhile, in the run-up to Medica 2017, German manufacturers were reporting both moderate business growth and increasing concern about reimbursement issues and the EU MDR and IVDR, which are making life less predictable for medtech innovators.
The EU Roadmap has been published. But it represents a dawning of a hard truth. The EU medtech sector still has a long way to go along the road to implementation before it gets the clarity it needs.
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