European IVD Companies See Worrying Trend In Market Access Barriers
Are medtech regulators and authorities in wider Europe – including Russia – setting market access barriers too high, risking investment in innovation and potentially denying patients access to modern care? European Diagnostic Manufacturers Association (EDMA) representative Christian Parry fears so, in this second half of our industry update from the 2015 European MedTech Forum.
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Uncertain Reg Climate Could Turn Medtech Investors Off Europe
A key stage in the EU process of adopting and implementing new regulations for medical devices and diagnostics was reached with the recent series of debates – the Trilogues – between the European Commission, the Parliament and Council of the EU. But matters are poised on a knife edge and are not always moving as quickly as or in the way local industry wants.
Pivotal Opportunity For UK Medtech Must Not Be Wasted
The UK continues to work on its new medtech regulatory system and market access processes for innovations, but all the planning and preparations will count for little if not accompanied by sound execution, warns Lincoln Tsang of law firm Ropes & Gray.
EU MDR Extended Transitions: Practical Advice From Commission
Concerns and uncertainties arising among manufacturers following the recent extension of the MDR's transition periods have been addressed in a question-and-answer document issued by the European Commission.