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Media Centre >> News >> Eurofins | July 2019 regulatory Newsflash compilation | Medical Devices

Eurofins | July 2019 regulatory Newsflash compilation | Medical Devices

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Tuesday, July 9, 2019

Eurofins newsflash Medical Device

 

Europe

 

Recent publications by European Commission

 

Below you will find a Decision recently published in the Official Journal of the European Union related to Medical Devices:

 

Date

Reference

Title

7-6-2019

C/2019/4068

Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices.

 

Europe/International

 

Standards Updates

 

Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

Reference

Title

Date of Withdrawal (*)

Supersedes

EN IEC 60601-2-16:2019

Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

2022-05-24

EN 60601-2-16:2015

EN IEC 60601-2-39:2019

Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment.

2022-05-24

EN 60601-2-39:2008
EN 60601-2-39:2008/A11:2011

EN 60601-2-54:2009/A2:2019

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.

2022-05-24

 

EN IEC 60601-2-76:2019

Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment.

2022-05-24

 

EN IEC 80601-2-30:2019

Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers.

2022-05-24

EN 80601-2-30:2010
EN 80601-2-30:2010/A1:2015

 

US

 

FDA proposes ventilatory electrical impedance tomograph into Class II

 

The US Food and Drug Administration (FDA) has recently notified to World Trade Organization the following:

 

Notification number / Link

Country

Title

G/TBT/N/USA/1493

US

Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph.