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"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.
Latest From Europe, Policy & Regulation
The current European Commission medtech working group structure has evolved over the last 25 years. Now some changes are needed.
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.
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?
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.
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