The Medical Devices Regulation (MDR) supersedes Directives 93/42/EEC and 90/385/EC, and this new law adopted by the European Parliament must be followed by medical devices manufacturers. The audits will be carried out by the “notified bodies”, the inspection agencies that review and assess the technical documentation for medical technology and have the legal power to shut down a company if the relevant requirements are not attended. The period to submit the audit required by the regulation is three years, up to May 2020. If we assume that the notified bodies can carry out the audits in about one year, thus the manufacturers will have only about two years to implement the MDR. Be prepared! This is an extremely tight time schedule. Click here to learn how to meet the requirements and save money!
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