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Set Alert for Policy and Regulation - Europe

MDR/IVDR Corrigenda Due Final Sign Off Soon; Big Changes For Devices, Less So For IVDs

The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.

EU Europe In Vitro Diagnostics

Latest From Policy, Regulation & Europe

Global Medtech Guidance Tracker: November 2019

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-eight guidance documents have been posted on the tracker since its last update.

International India

Competent Authorities Drive Unilateral Eudamed Delay Decision Onto Council Of EU Agenda

The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”

Medical Device Europe

EU Regulatory Roundup, November 2019: Big Changes For Medtech Regs Implementation

With six months left to the full implementation of the EU’s Medical Devices Regulation, there are a couple of big shifts taking place in the way it is being applied. Following news of the Eudamed database two-year delay, confirmation looks imminent that many more products will avoid having to comply with the MDR by next May. But will this plan sufficiently alleviate implementation pressures?

Europe Blocs

Eudamed Timelines: Unraveling Contradictory Legislation To Understand How The Deadlines Apply – A Lawyer’s View

The new version of the Eudamed database has been delayed – the European Commission says by two years. But how extensive is the delay? Fieldfisher partner, Alison Dennis, explains why the medtech sector needs to be cautious about how it interprets the latest developments.

Europe EU

UK Medtech Industry Targets A National Diagnostics Strategy

NHS England’s Long Term Plan puts much emphasis on better use of diagnostic tools in health-care delivery. The UK medtech industry is now pressing for a strategy to ensure that these technologies are factored into all patient pathways. It says the data derived will be used to improve patient outcomes and system efficiency.

United Kingdom Policy

Irish Regulator Invites Feedback On Strategic Plan For 2021-2025

Ireland’s drug and medical device regulator is seeking stakeholder views on what its priorities should be over the next five years, given the uncertainties of Brexit and impending regulatory changes.

Ireland Policy
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