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2012R0036 EN 14.10.2015 026.001 1 This document is meant purely as a documentation tool and the institutions do not assume any liability for its contentsBCOUNCIL REGULATION (EU) No 36/2012 of 18 January
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What is technical documentation and medical?
Technical documentation and medical refers to the detailed information, instructions, and records related to the development, testing, and usage of medical devices or equipment.
Who is required to file technical documentation and medical?
Manufacturers, distributors, and importers of medical devices are required to file technical documentation and medical.
How to fill out technical documentation and medical?
Technical documentation and medical should be filled out accurately and thoroughly, following the guidelines and regulations set forth by the regulatory authorities.
What is the purpose of technical documentation and medical?
The purpose of technical documentation and medical is to ensure the safety, effectiveness, and quality of medical devices, as well as to provide necessary information for regulatory compliance and approval.
What information must be reported on technical documentation and medical?
Technical documentation and medical must include information about the design, manufacture, performance, testing, labeling, and usage of the medical device.
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