This document is the letter of appointment of the person responsible for regulatory compliance (PRRC) in the event that the organization in which it performs the task is the Device Manufacturer and contains obligations and commitments of both parties in accordance with MDR (EU) 2017/745 and IVDR (EU) 2017/746.
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The information contained on this page and in the documents referred to is valid and current as of 07/17/23. Legislative and regulatory provisions are subjec to change and updating by the Regulatory Authorities. This being said, the writer declines all responsibility for any possible lack of topicality and/or accuracy of the information that may have occurred at the same time as or following the publication of this page and the documents referred to. Disclaimer