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Medical Devices / Regulatory Affairs

MedTech Europe Faults EU Standardization Plan for New Device Regs

June 3, 2019
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Harmonized standards are key for applying Europe’s new medical device and in vitro diagnostics regulations, but the European Commission’s latest draft of the standards to be considered is filled with technical errors that would results in a lack of standardization, MedTech Europe says.

The commission’s  standardization request includes a list of standards to be considered for harmonization under each regulation, and the request proposes timelines to adopt these standards. However, MedTech Europe said that if the standards were to be implemented, they would result in a deficiency of harmonized standards.

“This situation will lead to a lack of alignment between notified bodies with respect to the conformity assessment procedure and potential confusion within the system as a whole possibly allowing non-state-of-the-art products to enter the market,” MedTech Europe says in a new position paper.

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