Effective dates

Keeping up with the Effective Dates

Last updated 26 Feb 2019. You get up to date FDA effective dates here, and EU effective dates here.

FDA and EU effective dates

Medical Electrical Equipment Standard

FDA effective date

EU effective date (DOCOPOCOSS)

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

31 Dec 2018 (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 (2018 was 3 years old; see EU notes below)

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

1 Aug 2016

31 Dec 2017

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

since 4 Apr 2016

Not announced (2018 was 3 years old; see EU notes below)

Usability engineering, IEC 62366-1:2015

since 14 Aug 2015

Not announced (2018 was 3 years old; see EU notes below)

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

since 14 Aug 2015

Not announced (2017 was 3 years old; see EU notes below)

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. Where no EU effective dates is assigned, 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, and in fact 3 to 5 years after publication date, this may be the expectation of your notified body, but you should confirm expectations with your notified body.

Impact of IEC 60601-1-2, 4th Ed

See here.

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.