Medical Device Regulation (MDR) In Vitro Diagnostics ...

1 Copyright 2012 BSI. All rights reserved. Medical Device Regulation (MDR) In Vitro Diagnostics Regulation (IVDR) BSI Hanauer Landstra e 115, 60314 Frankfurt, Germany Milton Keynes, UK Copyright 2012 BSI. All rights reserved. 2 510(k) PMA Quality System Regulation MDR FDA 3rd Parties FDA FDA STED ISO13485:2003 QMS PMDA) PMDA) PMDA) MDD CE Marking TDF STED ISO13485:2003 Vigilance System Notified Body Notified Body Device License ISO13485:2003 Mandatory Reporting Health Canada Registrar Health Canada Copyright 2012 BSI. All rights reserved. 3 1998 1998 CE Copyright 2012 BSI.

2 All rights reserved. 4 notify Notified Body) MDD 93/42/EEC IVDD 98/79/EC AIMDD 90/385/EEC BSI U Copyright 2012 BSI. All rights reserved. 5 Medical Device Regulation (MDR) In Vitro Diagnostics Regulation (IVDR) 23/05/2014 regulations = = Copyright 2012 BSI. All rights reserved. 6 PIP breast implants 16 EU Commission , , , etc. : unannounced visits Copyright 2012 BSI.

3 All rights reserved. 7 European Commission prepared proposal 26 Sep 2012 New Commissioner in Sep 2014 European Parliament Committees working on counter proposals IMCO (113 IVD and 212 MDR amendment proposals), voting done EMPL (20 IVD and 60 MDR amendment proposals), voting done ENVI (399 IVD and 907 MDR amendment proposals), voting done First reading full Parliament 22 October 2013 open vote Full Parliamentary vote 3 April Re-elections May 2014 European Council of Ministers Just completed first read through Com proposal Plan to complete counter proposals before July 2014 Copyright 2012 BSI. All rights reserved. 8 3 Directives Regulations , AIMD 90/385/EEC , MDD 93/42/EEC , IVDD 98/79/EC Medical Device Regulation (MDR) In Vitro Diagnostics Regulation (IVDR) Regulation MDD/AIMD 3 IVD 3 Regulation EU Copyright 2012 BSI.

4 All rights reserved. 9 Regulation covering MD & AIMD Regulation covering IVD 2013 2014 2015 2016 2017 2018 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1ST Reading October 2013 but not achieved 2nd Reading Q4 2014 / Q1 2015 Designation of Notified Bodies 3 3 Copyright 2012 BSI. All rights reserved. 10 Regulation European Commission (EC) EU Member States (MS) EU Competent Authorities (CA) Medical Device Coordination Group (MDCG) Representatives of EU MS Medical Device Advisory Committee (MDAC) Expert committee of stakeholders, provides advice to MDCG, MS, EC Representatives from clinical experts, EMA and patients Assessment Committee for Medical Devices (ACMD) EU Reference Laboratories (EURL) European Medicines Agency (EMA) Notified Bodies (NB) Special Notified Bodies (SNB) 23/05/2014 Copyright 2012 BSI.

5 All rights reserved. 11 Medical Device - - - - - - Annex XV , manufacturer 23/05/2014 Copyright 2012 BSI. All rights reserved. 12 New Annex XV ; ; ; ; ; Copyright 2012 BSI. All rights reserved. 13 In Vitro Diagnostic Manufacturer ; ; ; ; ; DNA-testing Regulation .

6 5/23/2014 Copyright 2012 BSI. All rights reserved. 14 IVDs: Notified Body 80-90% Notified Body 80-90% Notified Body Notified Body IVD Directive IVD Regulation Copyright 2012 BSI. All rights reserved. 15 Economic Operators Manufacturer Importer Distributor Economic operators , , Copyright 2012 BSI. All rights reserved. 16 Supply Chain 5/23/2014 Crucial Suppliers Significant subcontractors OEMs Distributers Importers Authorised Representatives Manufacturer unannounced visits crucial suppliers significant subcontractors Copyright 2012 BSI.

7 All rights reserved. 17 , , , , / / : Copyright 2012 BSI. All rights reserved. 18 MDR AIMD class III class III class III / Sutures staples class III class III class III IVDR : A (lowest risk), B, C and D (highest risk) Copyright 2012 BSI.

8 All rights reserved. 19 - MDR Annex VIII Full Quality Assurance Annex II V VI unannounced visits ( ) Copyright 2012 BSI. All rights reserved. 20 Annex II QMS Class I Device ( / ) & CE Article 42 Point 5 Copyright 2012 BSI. All rights reserved. 21 & CE Class I Device ( / ) * / Article 42 Point 5 Annex II Annex VIII* QMS Annex X* Copyright 2012 BSI. All rights reserved. 22 Class IIa Device Annex II & CE Article 42 Point 4 Annex VIII Vigilance System Fulll Quality Assurance Annex X Copyright 2012 BSI. All rights reserved. 23 Class II b Device Annex IX & CE Article 42 Point 3 Annex VIII Vigilance System Fulll Quality Assurance Annex X Copyright 2012 BSI.

9 All rights reserved. 24 Class III Device Annex IX & CE Annex VIII Full Quality Assurance Annex VIII Annex X Article 42 Point 2 Article 44 MDCG Scrutiny Special Notified Bodies Copyright 2012 BSI. All rights reserved. 25 Safety and clinical performance report III Special Notified Body Special Notified Body Eudamed Safety and clinical performance report IVDR Safety and Performance Report class C D Copyright 2012 BSI. All rights reserved. 26 Clinical Evaluation Annex I Safety & Performance Requirement & Annex XIII 2 - - Annex XIV ( II) [ ] Copyright 2012 BSI.

10 All rights reserved. 27 QMS PMS Vigilance 61-66 PMS PMS Post Market Clinical Follow-up Annex XIII 61 Copyright 2012 BSI. All rights reserved. 28 Notified Bodies : Administrative / Technical/Scientific / Medical / Pharmacological Notified Body Commission MDCG 3 Special Notified Bodies Special Notified Body EMA clinical experts 2 23/05/2014 Copyright 2012 BSI. All rights reserved. 29 Special Notified Body Special Notified Bodies NB MDR class III, , class IIb IVDR class D EMA Special Notified Bodies EC IFU safety and clinical performance Copyright 2012 BSI.