changing regulatory requirements for electronic medical devices

FDA REGISTERED / ISO 13485 CERTIFIED

Dirk Smith Co-Founder Minnetronix Inc.

Changing Regulatory Requirements for Electronic Medical Devices


250 employees, 20 years in business 130+ Class II/Class III device programs in our history

100+ engineers with over 1.5M development hours on complex electromechanical medical devices, including drug delivery devices

FDA-registered, ISO 13485 Certified

Our medical device background: • Development partner • Med device manufacturer • Technology developer


A Brief Survey of Recent Regulatory and Compliance Changes • Objective

– Discuss the current general landscape of compliance

– Provide a sample of impactful changes – Point to standards and resources for further

information

• Focus on device compliance of electronic, electromechanical and programmable devices


Medical Device Regulatory Affairs

EU Medical Device Directive 21 CFR 800 Series

Other country-specific law

Quality Management System

ISO 13485 21 CFR Part 820

International Laws

Device Approvals CE-Mark

FDA Clearance/Approval International Approvals

Device Compliance Medical Device Standards

Guidance Documents Non-med Cert’s/Licenses

Scope For This Talk: Device Compliance

IEC 60601


ME Standards History: Editions and Major Amendments

1972 (US), UL (Underwriters Laboratories) published the UL 544 standard for medical and dental equipment (new medical standard) 1977, IEC 601-1, Edition 1 published for medical equipment (new medical standard) 1988, IEC 601-1, Edition 2 published (revised standard) 1994 (US), UL 2601-1, Edition 1 standard published (harmonized with IEC 60601-1, Edition 2 + Amendment 1 + US Deviations) 2005, IEC 60601-1, Edition 3 published (Completely revised standard) 2005 (US), AAMI published the AAMI ES 60601-1 standard (harmonized with IEC 60601-1, Edition 3 + US Deviations). This marked the transition of the US National medical standards from UL to AAMI. 2012, Amendment 1 to IEC 60601-1, Edition 3 published, re-named Edition 3.1 (major corrections to standard) 2012 (US), ES 60601-1:2005(R)2012 published (harmonized with IEC 60601-1, Edition 3 with Amendment 1 – Edition 3.1)


IEC 60601-1: Medical electrical equipment – Part 1- General requirements for basic safety and essential performance

or Rules of the Road?

Hurdles?

Required Path?


Current Device Compliance Landscape • Overall goal remains unchanged – safety

• Increased complexity of standards, coincident with

increased complexity of devices

• Harmonization of international standards

• Emphasis on risk management

• Hot Topics: usability, connectivity and compatibility


60601-1, 2nd to 3rd Editions

• 3rd edition published 2005, widely recognized/required by 2013 • Nearly worldwide harmonization (China pending) • 100 pages longer, new approach, not “backward compatible” • Risk assessment and process requirements (ISO 14971) • Emphasis on Basic Safety AND Essential Performance • Electrical safety in terms of Operator and Patient protection • Incorporation of PEM (SW) requirements into the standard • Many specific mechanical, electrical and labeling changes

Intertek White Paper: IEC 60601-1: The New Philosophy of the 3rd Edition, Sept 2010 http://60601-1.com/download.html


60601-1: Basic Safety and Essential Performance • Basic Safety

– “freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION”

– Examples: shock, drop, burn, pinch….

• Essential Performance – Performance necessary to achieve freedom from

unacceptable RISK – NOTE Essential Performance is most easily understood by

considering whether its absence or degradation would result in an unacceptable RISK

– Failure to provide essential performance is an unacceptable RISK, in normal and single fault conditions

– Examples: heating range on a warming blanket, flow accuracy on an IV pump


60601-1, Edition 3.1 • Published in 2014 • FDA Deadline for compliance: August 1, 2016 • EU transition January 1, 2018 • Clarifies application of risk management and

essential performance • Additional software and usability testing and

process requirements • Numerous mechanical, electrical, labeling

requirements changes

UL Whitepaper: The New Paradigm for Medical Device Safety Addressing the Requirements of IEC 60601-1 Edition 3.1, 2015


ISO 14971:2012 Application of Risk Management to Medical Devices

• ISO 14971 now specifically required by 601-1 • Notable change in latest version:

“AFAP” vs “ALARP” – As Far as Possible, no longer As Low as Reasonably

Practical” – Eliminates financial considerations from determination – Still maintains “state of the art” considerations for AFAP


ISO 14971:2012

Table from http://medicaldeviceacademy.com/en-iso-149712012-deviation-3-risk-reduction/

“ALARP” Approach

“AFAP” Approach


ISO 14971:2012

• When is enough Risk Mitigation enough? – When further mitigation does not further reduce risk – When a more effective, yet incompatible mitigation already exists

• Risk / Benefit Analysis – Required for all identified risks – An essential element in assessing acceptable risks and overall

residual risk for a product – Important to base on clinical risk and benefit – Useful to benchmark existing devices, objective evidence – At the end of the day, manufacturer responsible for process and

determination of acceptability of risk


601-1-2 Electromagnetic Compatibility Requirements and Tests

• 4th Edition, published 2014, required by FDA 4/2017

• ESD – air discharge to 15kV • Required data in labeling / IFU’s • Cell phone (wireless communications devices)

proximity requirements • Altitude considerations for operator insulation • General environmental requirements expanded


Additional “New” and/or Updated Collateral Standards

• 601-1-4, IEC 62304 (2006) – Medical device software – Lifecycle process, development and maintenance – Safety classifications and associated process and documentation requirements

• 601-1-6 (Ed. 3.1 2013) /IEC 62366 (2007) – Usability

– User-centered design process, requirements -> validation – Usability Engineering File

• 601-1-8 (Am. 1 2012) – Alarms

– Important to differentiate indicators and alerts from alarm – Audio alarm tones defined in the standard, by priority

• 601-1-11 (Ed. 2 2015) – Home Healthcare

– Environmental requirements; electrical, temp, drop, fluid ingress, etc. – User training and competency considerations in usability process – Data security, integrity, privacy


Guidance Documents and Peripheral Standards • Notable FDA Guidance Doc’s

– Applying HF and Usability – RF Wireless Technology in Medical Devices – Infusion Pumps Total Product Lifecycle – Management of Cybersecurity in Medical Devices – Content of Premarket Submissions for Software

• IEC 82304 – Health Software (draft)

– Applies to “stand-alone” software, not running on dedicated hardware

– Addresses full product lifecycle


Navigating the Compliance Roadway

• Regulatory landscape continues to change – Expect updated versions of standards and

guidance doc’s

• Complexity of standards continues to increase, as does the complexity of devices

• Many expert resources to assist developers – Development and manufacturing partners – Test agencies – Regulatory and compliance specialists


Questions/Comments?


Thank You!