Medical device CE marking

2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD

2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
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Last Updated	18 March 2020
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2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)

2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
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Size	898.86 KB
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Last Updated	18 March 2020
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2020-1 Clinical evaluation / Performance evaluation software

2020-1 Clinical evaluation / Performance evaluation software
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Size	968.56 KB
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Last Updated	18 March 2020
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2018-1 v3 Draft guidance on BASIC UDI-DI and changes to UDI-DI

2018-1 v3 Draft guidance on BASIC UDI-DI and changes to UDI-DI
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Size	151.87 KB
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Last Updated	18 March 2020
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The CND nomenclature – Background and general principles

The CND nomenclature – Background and general principles
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Size	993.16 KB
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Last Updated	18 March 2020
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The EMDN – The nomenclature of use in EUDAMED

The EMDN – The nomenclature of use in EUDAMED
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Size	336.34 KB
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Last Updated	18 March 2020
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2019-16 Guidance on cybersecurity

2019-16 Guidance on cybersecurity
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Size	1.69 MB
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Last Updated	18 March 2020
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2019-15 Guidance notes for manufacturers of class I medical devices

2019-15 Guidance notes for manufacturers of class I medical devices
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Size	184.51 KB
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Last Updated	18 March 2020
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2019-14 Explanatory note on MDR codes

2019-14 Explanatory note on MDR codes
MDCG ...

Size	180.30 KB
Downloaded	5 times
Last Updated	18 December 2019
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2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation

2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation
MDCG ...

Size	397.92 KB
Downloaded	7 times
Last Updated	18 December 2019
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