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There are hurdles to compliance with the EU Medical Device and IVD Regulations – but companies must jump them now. A look at why it's time for manufacturers to throw themselves into MDR/IVDR compliance, even if they will sometimes need follow their instinct rather than formal guidance.
Latest From Europe, Policy & Regulation
Little has been forthcoming from the European Commission about actions it is taking to get the new European regulatory framework for medical devices and IVDs ready on time. Now the European Parliament wants some answers.
Even though the Turkish government has settled some of the sizeable debt owed by hospitals to medical device and pharmaceutical suppliers, industry continues to be disgruntled over not being remunerated for the full amount owed and there continues to be wrangling over how the situation should be resolved.
Precious few details are available on the readiness of necessary structures and documents to support the EU's new Medical Device and IVD Regulations. But the current agenda of the Medical Device Coordination Group gives some insight.
The probability of a postponed entry-in-force of the single Eurasian Economic Union system of medtech regulation has increased over the course of this year, according to speakers at the 2018 Informa KNect 365 Medtech Summit. But the drive for stronger local medtech industries continues, leaving foreign manufacturers with market-access problems to address.
It looks as if the EU medtech regulatory system could survive intact in the UK, given terms of the UK blueprint for its future relationship with the EU after separation. But a storm of controversy must be navigated first.
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