Eurofins | July 2019 regulatory Newsflash compilation | Medical Devices
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 |
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. |
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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 |
|
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. |
2022-05-24 |
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Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment. |
2022-05-24 |
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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 |
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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 |
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Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. |
2022-05-24 |
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 |
|
US |
Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph. |
