1602)
ISO/IEC JTC1 SC22 WG21
ISO/IEC TS/SC22/WG21
ISO/IEC JTC1 SC23 L3
ISO/IEC JTC1 SC22/WG21 SC15.1 and SC22.1
ISO/IEC TS 17473
ISO/IEC JTC1 SC22 WG21
ISO/IEC TS 180054
ISO/IEC TS 17900:2011
ISO/IEC N1813:2004
ISO/IEC TS 17900:2009
ISO/IEC TS 18661:2012
ISO/IEC TS 18661:2013
ISO/IEC TS 18843:2016
ISO/IEC TS 2314.6
ISO/IEC JTC1 SC22/WG2
ISO/IEC TS 2314.7
ISO/IEC TS 2314.9
ISO/IEC TS 17951
ISO/IEC JTC1 SC22/WG3
ISO/IEC TS 17952
ISO/IEC TS 17998.1
ISO/IEC TS 17999:2012
ISO/IEC TS 17749:2016
ISO/IEC TS 17898:2012
ISO/IEC TS 17900:2014
ISO/IEC TS 17904 : 2014-01 (EEC No. 17000)
ISO/IEC TS 17904 : 2014-02 (EEC No. 17001)
ISO/IEC TS 17904 :2014-03 (EEC No. 17002)
ISO/IEC TS 17904 :2014-04 (EEC No. 17003)
ISO/IEC TS 17904 :2014-05 (EEC No. 16003)
ISO/IEC TS 17904 :2014-06 (EEC No. 16004)
ISO/IEC TS 17904 :2014-07 (EEC No. 16005)
ISO/IEC TS 17904 :2014-08 (EEC No.
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EU Module 1 Specification Version 1.4.1 November 2011 Document Control Change Record Version Date Author(s) Comments 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 0.91 0.92 0.93 0.95.1 0.95.2 0.95.3 1.0 1.1
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What is eu module 1 specification?
The eu module 1 specification is a set of guidelines and requirements that govern the submission of technical documentation for medical devices in the European Union.
Who is required to file eu module 1 specification?
Manufacturers or authorized representatives of medical devices are required to file the eu module 1 specification.
How to fill out eu module 1 specification?
The eu module 1 specification can be filled out by providing the requested information and documentation according to the guidelines provided by the European regulatory authorities.
What is the purpose of eu module 1 specification?
The purpose of the eu module 1 specification is to ensure that medical devices meet the necessary safety and performance requirements before they can be placed on the market in the European Union.
What information must be reported on eu module 1 specification?
The eu module 1 specification requires manufacturers to provide information about their device, including its intended use, design, manufacturing process, clinical evaluation, and post-market surveillance.
When is the deadline to file eu module 1 specification in 2023?
The deadline to file the eu module 1 specification in 2023 may vary depending on the specific regulatory requirements and transitional periods for different types of medical devices. It is recommended to consult with the European regulatory authorities or seek legal advice for the exact deadline.
What is the penalty for the late filing of eu module 1 specification?
The penalty for the late filing of the eu module 1 specification may also vary depending on the specific regulatory framework and national legislation. It is advisable to consult with the European regulatory authorities or seek legal advice to determine the potential penalties.
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