MHRA Director of Devices concerned with proposed regulations

AMSTERDAM — Responding to concerns that the European Parliament’s recent report on medical device regulation, if inaugurated, would burden innovation efforts, one government representative agreed that the proposed legislation needs to be improved.Medicines and Healthcare Products Regulatory Agency Director of Devices John Wilkinson said the MHRA is “uncomfortable” with the ambiguous language in the proposed legislation, particularly in Article 44. “We end up with extreme uncertainty,” he said.

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