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Media Centre >> News >> Medical Devices | Monthly bulletin | November 2019

Medical Devices | Monthly bulletin | November 2019

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Wednesday, November 6, 2019

Eurofins newsflash Medical Device

 

Europe

 

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

2019/488/B

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

 

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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 60601-2-28:2019

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

EN 60601-2-28:2010

EN IEC 80601-2-49:2019

Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

2022-08-07

EN 60601-2-49:2015

EN ISO 80601-2-79:2019

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

EN ISO 10651-6:2009

EN ISO 80601-2-80:2019

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

EN ISO 10651-6:2009