md_sector_lang-req-table-mdr.html

<br><br><b><div>30.01.2024:</div>
<div><a href="md_sector_lang-req-table-mdr.html">Sprachentabelle</a></div><br>

<br><br><b><div>MDCG 2019-9 (Summary of safety and clinical performance A guide for manufacturers and notified bodies):</div>
<div><a href="md_mdcg_2019_9.html">MDCG 2019-9</a></div><br>

<br><br><b><div>2021-05-06 IMDRF:</div>
<div><a href="200318_IMDRF.html">IMDRF dokument</a></div><br>

<br><br><b><div>2013-12-09 UDI Guidience:</div>
<div><a href="2013-12-09_UDI_Guidance.html">UDI Guidance dokument</a></div><br>

<br><br><b><div>2019-09-17 BASIC UDI-DI:</div>
<div><a href="HIBC_solution_for_EU_MDR_Basic_UDI-DI.html">HIBC solution for EU MDR Basic UDI-DI</a></div><br>

<br><br><b><div>2019-03-12 MDCG 2019-1:</div>
<div><a href="MDCG 2019-1.html">MDCG guiding principles for issuing entities rules on Basic UDI-DI</a></div><br>
<div><a href="MDCG_2019-2.html">Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017</a></div><br>
<div><a href="MDCG_2018-1.html">Draft guidance on BASIC UDI-DI and changes to UDI-DI V2</a></div><br>

<br><br><b><div>2018-11-27 UDI Neue Dokumente:</div>
<div><a href="181105_UDI-Bericht_von_FDA.html">UDI Bericht von der FDA vom 05.11.2018</a></div><br>

<br><br><b><div>2018-10-30 UDI Dokumente:</div>
<div><a href="udiwg_2018_1_guidance_core_elements_en.html">UDIWG 2018-1: UDI Database, Definitions/Descriptions and formats of the UDI core elements</a></div><br>
<div><a href="UDI/mdcg 2018 1 draft guidance on basic udi_endocx.html">MDCG 2018-1: Draft guidance on BASIC UDI-DI and changes to UDI-DI</a></div>
<div><a href="UDI/mdcg_2018_2_nomenclature_en.html">MDCG 2018-2: Future EU medical device nomenclature Description of requirements</a></div>

<br><br><b><div>Neue UDI Dokumente:</div>
<div><a href="UDI/UDI2018_HIBC_1_HeO_IMDRF.html">MDCG 2018-3: Guidance on UDI for systems and procedure packs</a></div>
<div><a href="UDI/mdcg_2018_4_udi_core_spp_en.html">MDCG 2018-4: Annex: UDI database</a></div>
<div><a href="UDI/mdcg_2018_5_software_en.html">MDCG 2018-5: UDI Assignment to Medical Device Software</a></div>
<div><a href="UDI/mdcg_2018_6_art16_en.html">MDCG 2018-6: Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746</a></div>
<div><a href="UDI/mdcg_2018_7_languages_en.html">MDCG 2018-7: Provisional considerations regarding language issues associated with the UDI database (Annex VI, Part A Section 2 and Part B of the Medical Device Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR))</a></div>
</b><br>
<br><br><b><div>UDI Dokumente:</div>
<div><a href="UDI_2017-11-17.html">17.11.2017 - Unique Device Identification: Direct Marking of Devices</a></div>
<div><a href="UDI_2018-01-16.html">16.01.2018 - Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices</a></div>
</b><br><br><br>
<div><a href="MDSAP.html">MDSAP</a></div>
<div><a href="RDC 67 (ANVISA).html">RDC 67 (ANVISA)</a></div>
<div><a href="RESOLUTION – RDC N. 23, OF 04 APRIL, 2012 (ANVISA).html">RESOLUTION – RDC N. 23, OF 04 APRIL, 2012 (ANVISA)</a></div>
<div><a href="Resolution RDC 16 2013t (ANVISA).html">Resolution RDC 16 2013t (ANVISA)</a></div>
<div><a href="SOR-98-282 (CMDR).html">SOR-98-282 (CMDR)</a></div>
<br><div>Japan:</div>
<div><a href="japan/000207979_Japan.html">000207979_Japan</a></div>
<div><a href="japan/Japan-MHLW-Ord-169-QMS-compliance.html">Japan-MHLW-Ord-169-QMS-compliance</a></div>
<div><a href="japan/mhlw_no169_20140730_Japan.html">mhlw_no169_20140730_Japan</a></div>

<br><br><div>NEU:</div>
<div><a href="neu/ANVISA-DIRECTIVE-RDC-No7-10-FEBRUARY-2015.html">ANVISA-DIRECTIVE-RDC-No7-10-FEBRUARY-2015</a></div>
<div><a href="neu/RDC-183-2017.html">RDC-183 - 2017</a></div>
<div><a href="neu/Japan-2017.html">Japan-2017</a></div>
<br><br><div><a href="neu/2017_ch02_Japan_03.03.2018.html">2017_ch02_Japan_03.03.2018</a></div>

<br><br><div>FDA Questions:</div>
<div><a href="FDA/FDA_Questions.html">FDA Questions</a></div>
<div><a href="FDA/QSITGUIDE.html">QSITGUIDE</a></div>
<div><a href="FDA/US_FDA_Inspection_Expectations_whitepaper.html">US FDA Inspection Expectations whitepaper</a></div>