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Keeping up with the effective dates

posted May 11, 2016, 1:59 AM by Frank O'Brien   [ updated Jul 6, 2016, 9:10 AM ]

FDA and EU effective dates

Here’s a summary of upcoming FDA and EU effective dates for common Medical Electrical Equipment safety standards

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

Amendment 1:2012 to General Basic Safety and Essential Performance, IEC 60601-1:2005, ed 3.1

1 Aug 2016

31 Dec 2017

Electromagnetic Disturbance, IEC 60601-1-2:2014 (ed 4)

31 Dec 2018 (recently extended from 1 Apr 2017, announced 5 Jul 2016)

31 Dec 2018 (announced 13 May 2016)

Home health care, IEC 60601-1-11:2015 (ed 2)

1 Apr 2017

Not announced, 2017-2018 expected

Amendment 1:2015 to Software, IEC 62304-1:2006, ed 1.1

since 4 Apr 2016

Not announced, 2019 expected

Usability engineering, IEC 62366-1:2015

since 14 Aug 2015

Not announced, 2018 expected

Emergency medical services, IEC 60601-1-12:2014 (ed 1)

since 14 Aug 2014

Not announced, 2017-2018 expected

With FDA effective dates, these apply when seeking device clearance (510(k) or approval (PMA). They don’t apply for products already cleared/approved for US market.

With EU effective dates, these apply to all products placed on EU market after date. EU effective dates seem to be held up awaiting Annex Z to the EN standards (mapping to directive essential requirements). Consistent with maintaining state of the art it’s acceptable to use the newer (non-harmonized) standards to presume compliance with essential requirements, but you should confirm with your notified body. 

Impact of Amendment 1, IEC 60601-1, ed 3.1 

Amendment 1 to the general basic safety and essential performance safety standard for medical electrical equipment is required for new FDA submittals after 1 Aug 2016. Amendment 1 mostly makes the application of the base standards easier/clearer. For example, risk management records has been reduced, Y-capacitors in secondary circuits is clarified, and rough handling requirements for mobile equipment are reduced. New more stringent requirements, which would normally be applied anyway based on risk assessment, are 

  • lithium batteries are required to comply with IEC 62133, and 
  • software must comply with IEC 62304, in addition to existing clause 14.
  • when seeking CB cert, OD-2055, requires usability engineering to IEC 60601-1-6 and IEC 62366 to be within scope
  • NRTL/Can certifications remain valid without Amendment 1.

To demonstrate compliance to the new amendment, you’ll need new verification documents.

Impact of IEC 62366-1

The newer Usability Engineering standard is also required by FDA. There’s no fundamental changes, but things rather the process description evolves:
  • Human Factors Engineering is a synonym for Usability Engineering
  • Use Error Causes -- Perception, Cognition, or Action; compared with categories; Unintended Slip or Lapse, and Intended Mistake
  • Hazard Related Use Scenarios; identify, describe, categorize 
  • Evaluation types -- Formative (iterative), Summative (final); compare with verification (serial phases) and validation (final)
  • NRTL/Can certifications remain valid without IEC 62366-1

To demonstrate compliance to the new standard, you’ll need new verification documents.

Risk reduced As Far As Possible

As a reminder, the guidance document to help with the application of Annex ZA to the EU Risk Management Standard is available here, NBs Recommendation Group’s "Interim" Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012, Version 1.1, 13 October 2014. OBCM has a blog post with more information here, more information.

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