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330 331 332 </div> 333 334 </div> 335 </div> 336 </div> 337 </div> 338 </div> 339 <div class="diywebContent"> 340 <div class="diywebLiveArea"> 341 <div class="diywebMainGutter"> 342 <div class="diyfeGridGroup diyfeCA diyfeCA1"> 343 <div class="diywebMain diyfeGE"> 344 <div class="diywebGutter"> 345 346 <div id="content_area"> 347 <div id="content_start"></div> 348 349 350 <div id="matrix_52558" class="sortable-matrix" data-matrixId="52558"><div class="n module-type-header diyfeLiveArea "> <h1><span class="diyfeDecoration">NBOG Reports and News</span></h1> </div><div class="n module-type-table diyfeLiveArea "> 351<div id="table_6748367"> 352 <div class="tableContainer" id="table_6748367_container"> 353 <table border="0" cellpadding="3" cellspacing="0"> 354<tbody> 355<tr> 356<td style="width: 741px;"><strong>Title</strong></td> 357<td style="width: 133px;"><strong>Publication</strong></td> 358</tr> 359<tr> 360<td style="width: 741px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_WD_2017_1_Draft_MDR_IVDR_application_dossier_Aug_2017.pdf" target="_blank">NBOG WD 2017-1 Draft list of documents to be submitted 361in the application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746</a></td> 362<td style="width: 133px;"><span style="color:#131ADA;">Aug 2017</span><br/> 363Â </td> 364</tr> 365<tr> 366<td style="width: 741px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_WD_2017_2_Draft_MDR_designation_codes_Aug_2017.pdf" target="_blank">NBOG WD 2017-2 Draft list of codes and corresponding types of 367devices for the purpose of specifying the scope of the designation of notified bodies under the Regulation (EU) 2017/745 (MDR)</a></td> 368<td style="width: 133px;"><span style="color:#131ADA;">Aug 2017</span><br/> 369Â </td> 370</tr> 371<tr> 372<td style="width: 741px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_WD_2017_3_Draft_IVDR_designation_codes_Aug_2017.pdf" target="_blank">NBOG WD 2017-3 Draft list of codes and corresponding types of 373devices for the purpose of specifying the scope of the designation of notified bodies under the Regulation (EU) 2017/746 (IVDR)</a></td> 374<td style="width: 133px;"><span style="color:#131ADA;">Aug 2017</span><br/> 375Â </td> 376</tr> 377</tbody> 378</table> 379<p>Â </p> </div> 380 <div class="c"></div> 381</div> 382
383<script type="text/javascript"> 384jQuery(function() { 385 if (Modernizr.touch) { 386 diy.module.tableModule.initFadeScroll("#table_6748367"); 387 } 388}); 389</script>
389 390 </div><div class="n module-type-text diyfeLiveArea "> <p>The draft Commission Implementing Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of 391medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of 392the Council was open for public feedback until 25 October 2017.</p> 393<p>On 10 November 2017 the Committee on Medical Devices favourably voted on the above draft Implementing Regulation. It has been adopted on 23 November 2017 and published as <a href="http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2017.309.01.0007.01.ENG&toc=OJ:L:2017:309:TOC" target="_blank">Commission Implementing Regulation (EU) 2017/2185</a> in the 394Official Journal L 309/7 on 24 November 2017.</p> 395<p> </p> 396<p>On the <a href="https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#new_regulations" target="_blank">Commissionâs website</a> â section âImplementing measures for 397Regulationsâ â you will find this and additional information, e.g. a note on scheduling of joint assessments.</p> </div><div class="n module-type-table diyfeLiveArea "> 398<div id="table_351713"> 399 <div class="tableContainer" id="table_351713_container"> 400 <table border="0" style="width: 883px;"> 401<tbody> 402<tr> 403<td style="width: 750px;"><b>Title</b></td> 404<td style="width: 126px;"><b>Publication</b></td> 405</tr> 406<tr> 407<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written_Report_NBOG_to_MDEG_May_2015.pdf" target="_blank">NBOG Report to MDEG 28 May 2015</a></td> 408<td style="width: 126px;">Oct 2015</td> 409</tr> 410<tr> 411<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/FVO_Joint_Assessment_Programme_Final_Overview_Report_April_2015.pdf" target="_blank">FVO Joint Assessment Programme Final overview 412Report April 2015</a></td> 413<td style="width: 126px;">Apr 2015</td> 414</tr> 415<tr> 416<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written_Report_NBOG_to_MDEG_Nov_2014.pdf" target="_blank">NBOG Report to MDEG 17 November 2014</a></td> 417<td style="width: 126px;">Dec 2014</td> 418</tr> 419<tr> 420<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written_Report_NBOG_to_MDEG_Jan_2014.pdf" target="_blank">NBOG Report to MDEG 16 January 2014</a></td> 421<td style="width: 126px;">Feb 2014</td> 422</tr> 423<tr> 424<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/131112_NBOG_Coordination_Group_Joint_Assessment_Programme_Interim_Overview_Report.pdf" target="_blank">NBOG Coordination Group Joint 425Assessment Programme Interim Overview Report</a></td> 426<td style="width: 126px;">Nov 2013</td> 427</tr> 428<tr> 429<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/130827_NBOG_Coordination_Group_Summary_Joint_Assessment_Programme.pdf" target="_blank">NBOG Coordination Group Summary Joint Assessment 430Programme</a></td> 431<td style="width: 126px;">Nov 2013</td> 432</tr> 433<tr> 434<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written_Report_NBOG_to_MDEG_July_2013.pdf" target="_blank">NBOG Report to MDEG 9 July 2013</a></td> 435<td style="width: 126px;">Jul 2013</td> 436</tr> 437<tr> 438<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written+Report+NBOG+to+MDEG_Jan_2013.pdf" target="_blank">NBOG Report to MDEG 14/15 January 2013</a></td> 439<td style="width: 126px;">Jan 2013</td> 440</tr> 441<tr> 442<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_Feb_2011_content.pdf" target="_blank">NBOG Meeting 3 February 2011</a></td> 443<td style="width: 126px;">Apr 2011</td> 444</tr> 445<tr> 446<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/Written_Report_NBOG_MDEG_Nov_2010.pdf" target="_blank">NBOG Report to MDEG November 2010</a></td> 447<td style="width: 126px;">Dec 2010</td> 448</tr> 449<tr> 450<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_July_2010_content.pdf" target="_blank">NBOG Meeting 1 July 2010</a></td> 451<td style="width: 126px;">Nov 2010</td> 452</tr> 453<tr> 454<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_Feb_2010_content1.pdf" target="_blank">NBOG Meeting 4 February 2010</a></td> 455<td style="width: 126px;">Apr 2010</td> 456</tr> 457<tr> 458<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_Report_to_MDEG_Nov_2009.pdf" target="_blank">NBOG Report to MDEG November 2009</a></td> 459<td style="width: 126px;">Nov 2009</td> 460</tr> 461<tr> 462<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_June_2009_content1.pdf" target="_blank">NBOG Meeting 24 June 2009</a></td> 463<td style="width: 126px;">Nov 2009</td> 464</tr> 465<tr> 466<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_report_2005_2008.pdf" target="_blank">NBOG Report for the Period 2005 - 2008</a></td> 467<td style="width: 126px;">May 2009</td> 468</tr> 469<tr> 470<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_Jan_2009_content.pdf" target="_blank">NBOG Meeting 14 January 2009</a></td> 471<td style="width: 126px;">Feb 2009</td> 472</tr> 473<tr> 474<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_report_2005_2008.pdf" target="_blank">NBOG Report at MDEG 9 December 2008</a></td> 475<td style="width: 126px;">Feb 2009</td> 476</tr> 477<tr> 478<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_Nov_2008_content.pdf" target="_blank">NBOG Meeting 13 November 2008</a></td> 479<td style="width: 126px;">Feb 2009</td> 480</tr> 481<tr> 482<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_June_2008_content.pdf" target="_blank">NBOG Meeting 27 June 2008</a></td> 483<td style="width: 126px;">Jul 2008</td> 484</tr> 485<tr> 486<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_Jan_2008_content.pdf" target="_blank">NBOG Meeting 15 January 2008</a></td> 487<td style="width: 126px;">Jan 2008</td> 488</tr> 489<tr> 490<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/NBOG_meeting_June_2007_content.pdf" target="_blank">NBOG Meeting 12 June 2007</a></td> 491<td style="width: 126px;">Jun 2008</td> 492</tr> 493<tr> 494<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/nbog_report_2004.pdf" target="_blank">NBOG Report for the Year to 31 December 2004</a></td> 495<td style="width: 126px;">Apr 2004</td> 496</tr> 497<tr> 498<td style="width: 750px;"><a href="http://www.doks.nbog.eu/Doks/nbog_report_2003.pdf" target="_blank">NBOG Report for the Period to 31 December 2003</a></td> 499<td style="width: 126px;">May 2004</td> 500</tr> 501</tbody> 502</table> </div> 503 <div class="c"></div> 504</div> 505
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512 513 </div><div class="n module-type-header diyfeLiveArea "> <h1><span class="diyfeDecoration">Resolutions of Competent Authority Meetings on Medical Devices</span></h1> </div><div class="n module-type-table diyfeLiveArea "> 514<div id="table_351715"> 515 <div class="tableContainer" id="table_351715_container"> 516 <table border="0" style="width: 888px;"> 517<tbody> 518<tr> 519<td style="width: 749px;"><strong>Title</strong></td> 520<td style="width: 132px;"><strong>Publication</strong></td> 521</tr> 522<tr> 523<td style="width: 749px;"><a href="http://www.doks.nbog.eu/Doks/Prague_resolution_recast_EU2009CZ.pdf" target="_blank">Prague Resolution on recast of medical devices directives</a></td> 524<td style="width: 132px;">Jul 2009</td> 525</tr> 526<tr> 527<td style="width: 749px;"><a href="http://www.doks.nbog.eu/Doks/Prague_resolution_counterfeitingEU2009CZ.pdf" target="_blank">Prague Resolution on counterfeit medical devices</a></td> 528<td style="width: 132px;">Jul 2009</td> 529</tr> 530<tr> 531<td style="width: 749px;"><a href="http://www.doks.nbog.eu/Doks/Brdo_Resolution_EU2008SI.pdf" target="_blank">Brdo Resolution</a></td> 532<td style="width: 132px;">Feb 2008</td> 533</tr> 534<tr> 535<td style="width: 749px;"><a href="http://www.doks.nbog.eu/Doks/Bonn_resolution_EU2007DE.pdf" target="_blank">Bonn Resoultion</a></td> 536<td style="width: 132px;">Feb 2007</td> 537</tr> 538<tr> 539<td style="width: 749px;"><a href="http://www.doks.nbog.eu/Doks/Vienna_Resolution_EU2006AT.pdf" target="_blank">Vienna Resolution</a></td> 540<td style="width: 132px;">Apr 2006</td> 541</tr> 542</tbody> 543</table> </div> 544 <div class="c"></div> 545</div> 546
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