FREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS

Transcription

1 FREQUENTLY ASKED QUESTIONS DURING ELECTRO-MEDICAL DEVICE MARKET ACCESS Helping You to Access Global Markets FAST and PREDICTABLY Vishal Thakker, MEng(Hons), AMIMechE Scheme Manager/Product Specialist BSI Group T: M: Stefan Hofmann Team Lead Medical / Head of Laboratory CSA Group Europe GmbH T: F: Info.europe@csagroup.org 1

2 CSA Group & BSI Strategic Alliance 2

3 Which standards apply for medical devices under the Medical Device Directive (MDD)? 3

4 Which standards apply for Medical devices under the Harmonized standards MDD? See for the complete list. State of the Art See IEC and/or ISO Website for the latest standards 4

5 5

6 How can we document that we comply with a certain standard? 6

7 How can we document that we comply with a standard? You can use official test report forms with the following header: Cl. Requirement Test Result Verdict and additional test result tables, where ISO requirements are fulfilled. For example: IECEE TRFs for the Familiy 7

8 Why must we do the evaluation for process standards and have a testing and certification organization like CSA review it? 8

9 Why must we do the evaluation for process standards and have a testing and certification organization like CSA review it? Manufacturers responsibility Released documents (SOPs / WIs) Output documents 9

10 What is the process for evaluating Software to the standard? 10

11 What is the process for evaluating Software to the standard? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) Hazards covered? Measures effective & implemented? 11

12 What is the process for evaluating Risk Management to

13 What is the process for evaluating Risk Management to ? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) All applicable clauses in IEC covered? 13

14 What is the process for evaluating Usability to ? 14

15 What is the process for evaluating Usability to ? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) All applicable hazards covered? 15

16 When will the revised version of IEC be released? 16

17 When will the revised version of IEC be released? Amendment 2 scheduled for Q4/2019 Edition 4 scheduled for

18 Roadmap Family nd A A rd A A th IEC Medical Electrical Equipment Part 1: General Requirements for Safety IEC Medical electrical equipment, Part 1: General requirements for basic safety and essential performance IEC Medical Electrical Equipment 18

19 When will China begin accepting the 3 rd edition of ? 19

20 When will China begin accepting the 3 rd edition of ? China: scheduled to publish in

21 What is expected to change in , Amendment 2? 21

22 What is expected to change in , Amendment 2? Partial clarifications and changes Should not have impact on collateral or particular standards Maintenance teams to start work in late

23 When will the 4 th edition of be required? 23

24 When will the 4 th edition of be required? Depending on individual country Canada, USA, EU effective January 1st,

25 How will the evaluation to the 4th edition be conducted? 25

26 How will the evaluation to the 4th edition be conducted? Risk management introduced Test plan needed from the manufacturer to do testing 26

27 What documentation is needed for a CE mark, and how can a self-declaration be conducted? 27

28 What documentation is needed for a CE mark, and how can a self-declaration be conducted? Class I Class IIa Class IIb Class III Dependent on device intended use Low Medium High 28

29 Can existing EN harmonized Part 2 standards, that are aligned with the 2 nd edition of , still be used? 29

30 Can existing EN harmonized Part 2 standards, that are aligned with the 2 nd edition of , still be used? Harmonized standards (IEC ) refer to the 2 nd edition of IEC Jurisdictions will ask if comply with the state of the art. Manufacturers must demonstrate compliance with the Essential Requirements Compliance with harmonized standards provides a presumption of compliance with relevant Essential Requirements 30

31 Are any changes in relationship between the current Directives/new MDRs and the standards? 31

32 Are any changes in relationship between the current Directives/new MDRs and the standards? All standards must be harmonized under the MDR Wording in the MDR reads: References in the present regulation to harmonized standards shall be understood as meaning harmonized standards, the references of which have been published in the Official Journal of the European Union. Annex Z will need to be revised 32

33 Will a new EU harmonized list coincide with the new MDR? 33

34 Will a new EU harmonized list coincide with the new MDR? - List of harmonized standards will be updated - Common Specifications created 34

35 What is the plan for implementation of the new Medical Device Regulation (MDR)? 35

36 What is the plan for implementation of the new Medical Device Regulation (MDR)? 36

37 What are the requirements of only providing instructions electronically? 37

38 What are the requirements of only providing instructions electronically? Professional use? Software Only? 38

39 Do adverse incidents not occurring in the EU have to be reported to the Notified Body? 39

40 Do adverse incidents not occurring in the EU have to be reported to the NB? Not just the EU! 40

41 How do the Requirements of MEDDEV Revision 4 for clinical evaluation affect manufacturers? 41

42 How do the Requirements of MEDDEV Revision 4 for clinical evaluation affect manufacturers? New version: Some new requirements Clarification on existing guidance en-gb/documents/meddev-brochure.pdf 42

43 What is the Medical Device Single Audit Program, and what does it mean for medical device manufacturers? 43

44 What is the Medical Device Single Audit Program, and what does it mean for medical device manufacturers? One Auditing Organization conducts audits to requirements of multiple Regulatory Authorities 44

45 When do I need to comply with the new version of ISO 13485? 45

46 When do I need to comply with the new version of ISO 13485? ISO 13485:2016 Transition Timeline 46

47 Thank you Questions? 26

48 Contact Helping You to Access Global Markets FAST and PREDICTABLY 48