European CE Marking of Medical Devices. October 2017
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- Elisabeth Merritt
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1 European CE Marking of Medical Devices October
2 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
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 3
4 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
5 Total - AIMD, MD, IVD 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 Medical Devices Notified Bodies
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 6
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 7
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 MDR, Annex I, SPR#10.4 8
9 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
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 10
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 JRC Expert Panels 11
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 12
13 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
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 14
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 15
16 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
17 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
18 Requirements EU Regulations Clinical Oversight Joint Assessments Unannounced Audits Interim Regulations & Recommendations Future Regulation 2017 Time 18
19 BSI Medical Devices 19
20 EU MDR / IVDR Designation Article / November
21 EU MDR / IVDR Designation Article / November
22 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
23 Designation Pilot Audits Volunteers required Quality System Audits Unannounced Audits Microbiology & Sterilisation Audits Class I Reusable Technical Documentation Reviews 23
24 Webinars Whitepapers Roadshows 24
25 25
26 Questions Thank You! 26
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