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Set Alert for Policy and Regulation - Europe

MDR And IVDR Fail Risk-Benefit Assessment, EU Reg Expert Says

"I fail to see any merit in this piece of dismally bad legislation. It is absolutely in no one’s interest," says consultant and regulatory expert Jaap Laufer, who predicts disastrous impact on many companies and the end of notified bodies as we know them.

Europe Regulation Medical Device

Latest From Europe, Policy & Regulation

European Commission Sorts Medtech Working Groups And Creates New One

The current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.

Europe Medical Device

QUOTED. Dec 15, 2017. Jaap Laufer.

Emergo's Jaap Laufer says the oncoming Medical Device and IVD Regulations have serious flaws that could lead to the demise of the EU notified body system. Check out what he says might result.
Europe Regulation

UK Device Manufacturers Must Contingency Plan For A Hard Brexit

The compromise tone adopted last week by the UK government on key "phase 1" issues of an EU-UK Brexit deal was welcomed by UK health-care products industries, but with uncertainty over phase 2 – the future EU trade deal – still hampering UK business planning, local companies have no choice but to begin contingencies for a hard Brexit. Overseas stakeholders are also starting to distance themselves from a UK still unable to commit to a post-2019 relationship with the EU27.

United Kingdom Brexit

QUOTED. Dec 12, 2017. Nathalie Moll.

Check out what the European Federation of Pharmaceutical Industries and Associations' Nathalie Moll had to say about life-science industry alignment on Brexit.
Brexit Medical Device

Will Brexit Negotiations Move To Devices Soon?

It's been a long and painful journey, but some progress has finally been made in Brexit talks. It is looking hopeful now that a "hard Brexit," or no-deal Brexit, is unlikely. Is there more good news coming for devices?

Brexit Medical Device

EMA Warns Device Sector That Relocation Could Hinder Device Approvals

The EMA does not just regulate drugs. It plays a vital role with some drug/device combination products and borderline products. Just as that role is expanding, relocation threatens to cause a hiatus for device-type products.

Europe Medical Device
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