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Set Alert for Policy and Regulation - Europe

New EU Regs: Clues To Which Notified Bodies Will Be Designated First

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.

Europe Medical Device Policy & Regulation

Latest From Europe, Policy & Regulation

Combining EU Notified Body MDR/IVDR Assessments: Can It Speed Things Along?

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?

Medical Device Europe

Political Bargaining Intensifies In Final Days Before Vote On EMA’s New Home

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.

Regulation Europe

'Old-Fashioned' Medical Device Regulation? New Regulatory Regime For EU Medtech In Wings

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.

Medical Device Europe

EU Commission May Be Swamped As Notified Bodies Race To Start Line

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?

Medical Device Europe

Germany's Medica 2017 Kicks Off Amid Changeable Outlook, As MDR Clouds Scud Into View

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.

Germany Market Access

EU Roadmap: Catalyst For More Work, And A Long Way To Go

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.

Medical Device Europe
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