Medical Devices | Monthly bulletin | November 2019
Regulatory proposals notified to European Commission
Below a summary table with some recent notifications to European Commission (non-exhaustive):
|
Country |
Notification number / Link |
Title |
|
Belgium |
PRELIMINARY DRAFT ACT ON MEDICAL DEVICES The preliminary draft Act supplements and lays down procedures for the application of Regulation 2017/745 and Chapter IV of Regulation 2017/746, before its entry into force on 25 May 2020 |
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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis |
2022-08-07 |
||
|
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
2022-08-07 |
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|
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018) |
2020-03-31 |
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|
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018) |
2020-03-31 |
