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: +44 1908 814565 M: +44 7776 161579 Vishal.Thakker@bsigroup.com Stefan Hofmann Team Lead Medical / Head of Laboratory CSA Group Europe GmbH T: +49 69 509571 500 F: +49 69 509571 999 Info.europe@csagroup.org 1
CSA Group & BSI Strategic Alliance www.csagroup.org www.bsigroup.com 2
Which standards apply for medical devices under the Medical Device Directive (MDD)? 3
Which standards apply for Medical devices under the Harmonized standards MDD? See https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en for the complete list. State of the Art See IEC and/or ISO Website http://www.iec.ch https://www.iso.org for the latest standards 4
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How can we document that we comply with a certain standard? 6
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 17025 requirements are fulfilled. For example: IECEE TRFs for the 60601 Familiy 7
Why must we do the evaluation for process standards and have a testing and certification organization like CSA review it? 8
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
What is the process for evaluating Software to the 60601-1 standard? 10
What is the process for evaluating Software to the 60601-1 standard? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) Hazards covered? Measures effective & implemented? 11
What is the process for evaluating Risk Management to 60601-1 12
What is the process for evaluating Risk Management to 60601-1? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) All applicable clauses in IEC 60601-1 covered? 13
What is the process for evaluating Usability to 60601-1? 14
What is the process for evaluating Usability to 60601-1? Desktop assessment or on-site assessment Verification of process description (incl. documents & records) All applicable hazards covered? 15
When will the revised version of IEC 60601-1 be released? 16
When will the revised version of IEC 60601-1 be released? Amendment 2 scheduled for Q4/2019 Edition 4 scheduled for 2024 17
Roadmap 60601 Family 1988 2nd 1991 +A1 1995 +A2 2005 3rd 2012 +A1 2019 +A2 2024 4th IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety IEC 60601-1 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance IEC 60601-1 Medical Electrical Equipment 18
When will China begin accepting the 3 rd edition of 60601-1? 19
When will China begin accepting the 3 rd edition of 60601-1? China: scheduled to publish 60601-1 3.1 in 2018 20
What is expected to change in 60601-1, Amendment 2? 21
What is expected to change in 60601-1, Amendment 2? Partial clarifications and changes Should not have impact on collateral or particular standards Maintenance teams to start work in late 2017 22
When will the 4 th edition of 60601-1-2 be required? 23
When will the 4 th edition of 60601-1-2 be required? Depending on individual country Canada, USA, EU effective January 1st, 2019 24
How will the evaluation to the 4th edition be conducted? 25
How will the evaluation to the 4th edition be conducted? Risk management introduced Test plan needed from the manufacturer to do testing 26
What documentation is needed for a CE mark, and how can a self-declaration be conducted? 27
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
Can existing EN harmonized Part 2 standards, that are aligned with the 2 nd edition of 60601-1, still be used? 29
Can existing EN harmonized Part 2 standards, that are aligned with the 2 nd edition of 60601-1, still be used? Harmonized standards (IEC 60601-2-40) refer to the 2 nd edition of IEC 60601-1. 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
Are any changes in relationship between the current Directives/new MDRs and the 60601 standards? 31
Are any changes in relationship between the current Directives/new MDRs and the 60601 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
Will a new EU harmonized list coincide with the new MDR? 33
Will a new EU harmonized list coincide with the new MDR? - List of harmonized standards will be updated - Common Specifications created 34
What is the plan for implementation of the new Medical Device Regulation (MDR)? 35
What is the plan for implementation of the new Medical Device Regulation (MDR)? 36
What are the requirements of only providing instructions electronically? 37
What are the requirements of only providing instructions electronically? Professional use? Software Only? 38
Do adverse incidents not occurring in the EU have to be reported to the Notified Body? 39
Do adverse incidents not occurring in the EU have to be reported to the NB? Not just the EU! 40
How do the Requirements of MEDDEV 2.4.1 Revision 4 for clinical evaluation affect manufacturers? 41
How do the Requirements of MEDDEV 2.4.1 Revision 4 for clinical evaluation affect manufacturers? New version: Some new requirements Clarification on existing guidance https://www.bsigroup.com/meddev/localfiles/ en-gb/documents/meddev-brochure.pdf 42
What is the Medical Device Single Audit Program, and what does it mean for medical device manufacturers? 43
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
When do I need to comply with the new version of ISO 13485? 45
When do I need to comply with the new version of ISO 13485? ISO 13485:2016 Transition Timeline 46
Thank you Questions? 26
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