On Tuesday Feb 11, 2014 at the UBM Canon communications MD&M West Conference in the “Improving Risk Management Strategies And Procedures” track Leo Eisner of Eisner Safety Consultants spoke on the proposed Consensus Guidance Document on EN ISO 14971:2012 that is being drafted by NBRG (the Notified Body Recommendation Group). EN ISO 14971:2012 was harmonized under the 3 Medical Devices Directives on 30 Aug 2013 and was released with no transition period. So, this caused a lot of confusion and there still is a lot of confusion. To find out more read the presentation and also go to our blog post on the presentation at www.EisnerSafety.com/NBRG_Consensus_Document_On_EN_ISO_14971_2012_is_on-its-way/

1. 2/25/14
Will the confusion end soon ?
Consensus on
EN ISO 14971:2012
is on its way
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Agenda
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History
Industry Survey
Scope/Purpose of Consensus
Concepts for Consensus
Going forward - Tentative Timeline
Bottom Line
Resource Guide
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History
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30 Aug 2012
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OJEU publication EN ISO 14971:2012
Zero transition time = immediate withdrawal
of EN ISO 14971:2009
Annexes (ZA, ZB, ZC) indicate Significant
Changes with over 10+ yr practice
(Annexes Z list coverage of MDD Essential Requirements)
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Result " Confusion with Industry,
Notified Bodies, and Regulators
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History
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EU Industry Associations started develop
guidance
Same for Notified Bodies (+ training)
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Main driver “as low as possible” (EU Directives)
vs. “as low as reasonably possible” (ISO
14971:2007)
16 April 2013 – Team-NB Position Paper
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Describes how TEAM-NB members verify
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requirements EN ISO 14971:2012 are met, and
gaps closed with requirements of applicable directive
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3. 2/25/14
History
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Some Industry Associations published
guidances:
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COCIR draft (members only; Jan-Oct 2013)
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Spectaris (Germany) & ZVEI (Germany) – Sept
2013
EDMA (IVD-specific) – Nov 2013
Not released, no set timeline
COCIR observed: something is fundamentally
wrong with Annex Z’s, let’s discuss with NB’s
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History
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14 Oct 2013: COCIR presentation to NBRG
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NBRG: consider dedicated NBRG WG on RM
develop RM consensus document
16 Oct 2013: NB-MED semi-annual plenary
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Surprise: NB’s share concerns!
Approval of NBRG new WG on RM
10 Dec 2013 – NBRG WG RM kick-off Conf.
Call
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History
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22 Jan 2014 – NBRG WG RM Survey Conf.
Call
29 Jan 2014 – NBRG WG RM first face-toface meeting – Goals:
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Review literature, incl. COCIR & Spectaris papers
1st Consensus building – final draft Survey
7 Feb 2014 – Call for Industry Survey
Participation
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Industry Survey
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Goal: Develop better understanding current industry
practices in Risk Management along with EN
14971:2012
Survey https://www.surveymonkey.com/s/Y3CYPNP
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Anonymous responses
PLEASE participate & get as many to join
More responses " better understanding of current
practice across industry
Respond by 21 March 2014
Publish as aggregate data
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5. 2/25/14
Scope/Purpose of
Consensus
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Identify recent Risk Management best practices
(including Risk/Benefit evaluation)
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Consolidate different information sources:
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Survey response
FAQs (various Notified Bodies websites)
Medical Device Industry Associations Guidance
Documents
Harmonize way to apply ‘as far as possible’ via
NBRG Consensus Document
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Scope/Purpose of
Consensus
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Give practical guidance for:
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Industry: How apply requirements in practice
Notified Bodies: Enable to audit / approve industry
Risk Management Process in reasonable manner
Regulators (EU Commission, Competent Authorities):
How stakeholders in “the real world” deal with the
regulatory requirement of “as low as possible”
Eventual aim of Consensus Document: to remove current
confusion, advise on practical ways to enhance patient safety,
and close dispute on interpretation of “as low as possible”.
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6. 2/25/14
Going Forward – Tentative
Timeline
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7 Feb 2014 – Call for Survey
Participation
24 Feb 2014 – NBRG WG RM Conf.
Call – Consolidation of Industry
Association Papers
1st Draft NBRG RM Consensus
Document
21 March 2014 – Survey deadline
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Going Forward - Timeline
Tentative Timeline (April 2014)
!! 2 Apr – Final working draft of NBRG RM Consensus
Document (+ Survey results)
!! 9 Apr – Approved draft Consensus Document for
NBRG presentation & discussion
!! 14 Apr – NBRG WG RM Meeting & proposed
adoption
!! 16 Apr – Team-NB plenary & adoption for publication
on Team-NB Homepage
!! 18 Apr – Publication on Team-NB Homepage
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7. 2/25/14
Bottom Line
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Requirements from Medical Devices
Directives must be met for CE-mark
EN ISO 14971 may be used to claim
presumption of conformity with relevant
Medical Devices Directive requirements
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Resource Guide (Weblinks)
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8. 2/25/14
Resource Guide
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Annex ZA, ZB, ZC of EN ISO 14971:2012
Eisner Safety Blog Post on NBRG Call to
Industry Participation in Survey Understanding
Annex Z EN ISO 14971:2012
OJEU for EN ISO 14971:2012 for MDD
OJEU for EN ISO 14971:2012 for IVD
OJEU for EN ISO 14971:2012 for AIMDD
Team-NB Position Paper on EN ISO
14971:2012
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Resource Guide
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Team-NB
COCIR
Eucomed
EDMA
List of Notified Bodies under the MDD 93/42/EEC
List of Notified Bodies under the Active
Implantable Directive 90/385/EEC
List of Notified Bodies under the IVD Directive
98/79/EC
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9. 2/25/14
Resource Guide
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LinkedIn Group – IEC 60601 Series – Medical
Electrical Equipment
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The only IEC 60601 Group Owned by the IEC Central
Office Staff, Many of members are standards
committee members
http://www.linkedin.com/groups/IEC-60601-Series-MedicalElectrical-4860733/about
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Eisner Safety Consultants Monthly newsletter – Signup on our website at www.eisnersafety.com or contact
me directly @ Leo@Eisnersafety.com
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Resource Guide
(Weblinks)
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www.EisnerSafety.com/links/ includes links to:
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Certification Safety Agencies (NBs, Safety, EMC, QMS, etc.)
3rd Party Test Houses
Standards Organizations (ISO, IEC, UL, BSI, CEN,
CENELEC, AAMI, ANSI, CSA, JSA, VDE, etc.)
Standards Sales Organizations
Regulatory Agencies (includes GHTF)
Certification Databases
Electrical Test Equipment Suppliers
Language Translation Services
Add’l Regulatory & Compliance Resources
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10. 2/25/14
Resource Guide
(Weblinks)
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www.EisnerSafety.com/library/ includes links to:
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MDD consolidated version (2007/47/EC included)
Interpretative document on Implementation of MDD &
AIMDD
MDD List of Harmonized Standards
EU Languages List
MEDDEVs for Borderline Products (2.1/3), Classification
(2.4/1) Clinical Evaluation (2.7/1) , & Vigilance (2.12/1)
NB recommendations
EU Medical Device Sector Info Page (Great Europa link)
Various other Directives (Machinery, RoHS, WEEE, etc.)
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Leo Eisner Biography
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Leo is a registered Professional Engineer in the Safety
Engineering discipline. He has over 28 years experience in
the Product Safety arena and has worked for UL for 9 years
in a wide variety of product categories, and then joined TÜV
Product Service for 2 years specializing in electrical medical
products. He later joined Karl Storz Imaging and worked for
them as a Compliance Engineer and has been consulting for
over 16 years in product safety, quality systems, standards
development, CMDR and CE Marking. Leo has audited for
the Notified Bodies NSAI & TÜV P.S. authorized to audit to
EU MDD, CMDR, ISO 13485, & as a technical reviewer for
electro-medical devices.
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11. 2/25/14
Leo Eisner Biography
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Leo is the manager of a newly formed LinkedIn Group
IEC 60601 Series – Medical Electrical Equipment
He is a member of the US TAG for TC 62 (Electrical Equipment
in Medical Practice), SC 62A (Common Aspects of Electrical
Equipment Used in Medical Practice) and SC 62D
(Electromedical equipment). Leo is the convener of SC62D
JWG9 “Lens removal and vitrectomy devices for ophthalmic
surgery”. Leo is a member of RAPS, AAMI, ASQ, IEEE & the
Oregon Bioscience Association. Leo is a co-author for multiple
Cannon Communication magazine articles primarily with
MD&DI, MEM & Compliance Engineer. He has also written for
the Journal for Medical Device regulation. Leo is an Editorial
Advisory Board member of MD&DI.
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Contact Information
3331 SW Seymour Street
Portland, Oregon 97239
503-244-6151 (Phone)
503-244-6152 (Fax)
503-709-8328 (Cell)
Leo@EisnerSafety.com
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