European CE Marking of Medical Devices. October 2017

European CE Marking of Medical Devices October 2017 1

2017 EU Regulations Why? Response to scandals to restore confidence in system Keep pace with scientific and technical developments Overcome divergence in interpretation and application 2

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI 3

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI 4

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Total - AIMD, MD, IVD 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Audit Days 2017 EU Regulations Impact 1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI MHRA - Witnessed & Surveillance 35 30 25 20 15 10 5 0 Medical Devices Notified Bodies 100 80 60 40 20 0 5

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI 6

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI 7

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI MDR, Annex I, SPR#10.4 8

1. Better protection of public health and patient safety Strict pre-market control Inclusion of certain aesthetic devices Reinforced designation and oversight of Notified Bodies Reinforced rules on clinical / performance evaluation and clinical investigation / performance studies Strict rules for substance-based devices Strict rules for use of hazardous substances Introduction of UDI 9

2. Legal certainty and innovation-friendly environment Use of regulation as a regulatory tool Clarification of scope for both MD and IVDs Stronger role for the Commission on the regulatory status of products Clarification of regime applicable to devices manufactured and used in the same healthcare institution Clarification of responsibilities of economic operators New rules for software / apps 10

2. Legal certainty and innovation-friendly environment Use of regulation as a regulatory tool Clarification of scope for both MD and IVDs Stronger role for the Commission on the regulatory status of products Clarification of regime applicable to devices manufactured and used in the same healthcare institution Clarification of responsibilities of economic operators New rules for software / apps JRC Expert Panels 11

2. Legal certainty and innovation-friendly environment Use of regulation as a regulatory tool Clarification of scope for both MD and IVDs Stronger role for the Commission on the regulatory status of products Clarification of regime applicable to devices manufactured and used in the same healthcare institution Clarification of responsibilities of economic operators New rules for software / apps 12

2. Legal certainty and innovation-friendly environment Use of regulation as a regulatory tool Clarification of scope for both MD and IVDs Stronger role for the Commission on the regulatory status of products Clarification of regime applicable to devices manufactured and used in the same healthcare institution Clarification of responsibilities of economic operators New rules for software / apps 13

3. Increase transparency and patient empowerment Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available Introduction of an implant card to be provided to patients Summary of safety and performance for all Class III and implantable devices available in EUDAMED New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients 14

3. Increase transparency and patient empowerment Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available Introduction of an implant card to be provided to patients Summary of safety and performance for all Class III and implantable devices available in EUDAMED New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients 15

3. Increase transparency and patient empowerment Establishment of EU database on medical devices (EUDAMED) with a large part to be made publicly available Introduction of an implant card to be provided to patients Summary of safety and performance for all Class III and implantable devices available in EUDAMED New obligations for manufacturers and authorised representatives aimed at protecting consumers/patients device name serial number lot number Unique Device Identification device model manufacturer name, address and website any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions; any information about the expected lifetime of the device and any necessary follow-up; any other information to assure a safe use of the device by the patient including the information in point (u) Annex I, Section 23.4 Instructions for Use 16

4. European approach Registration of devices and economic operators Improved coordination between Member States in the fields of vigilance and market surveillance Strengthening EU Joint Assessment procedure for Notified Bodies Coordinated assessment of clinical investigations conducted in more than one Member State 17

Requirements 2007 2024 EU Regulations Clinical Oversight Joint Assessments Unannounced Audits Interim Regulations & Recommendations Future Regulation 2017 Time 18

BSI Medical Devices 19

EU MDR / IVDR Designation Article 38-40 / 38-40 26 November 2017 20

EU MDR / IVDR Designation Article 38-40 / 38-40 26 November 2017 21

NBOG Codes Notified Body Designation Orthopaedic Dental Active Implantable Devices Active Devices IVDs MDR n=70 IVDR n=85 Vascular General Devices Biological Substances Drug-Device Combination 22 16/10/2017

Designation Pilot Audits Volunteers required Quality System Audits Unannounced Audits Microbiology & Sterilisation Audits Class I Reusable Technical Documentation Reviews 23

Webinars Whitepapers Roadshows 24

http://www.bsigroup.com/en-us/medical-devices/ 25

Questions Thank You! 26