IEC 601-1-4 withdrawal

The new version of IEC 60601-1 (3rd edition, 2005) replaces IEC 60601-1-4, not just ISO 14971. IEC 60601-1-4 includes both risk management requirements and PEMS development process requirements.

IEC 60601-1-4 remains a harmonized standard in the EU to meet the essential requirement of the MDD on PEMS, if the 2nd edition of IEC 60601-1 is being referenced. It is superseded by the 3rd edition of IEC 60601-1, which includes the PEMS process requirements and a normative reference to ISO 14971. So, if compliance to the 3rd edition of IEC 60601-1 is being claimed, IEC 60601-1-4 is not necessary. After the transition period to the third edition of IEC 60601-1 is over, IEC 60601-1-4 will be withdrawn.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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