Medical Devices | Monthly bulletin | May 2020
Amending date of application – Medical device regulation
On 24th April 2020, the European Commission published the following regulation:
“Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions”.
This regulation postpones by one year, to 26 May 2021, the application date of medical device regulation.
Please click here to view the full Commission Regulation (EU) 2020/561 publication.
Recent publications by the European Commission
The below table summarises recent publications made by the Official Journal of the European Union relating to medical devices:
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Date |
Reference |
Title |
|
25-03-2020 |
Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC |
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03/04/2020 |
COMMISSION DECISION of 3.4.2020 on relief from import duties and VAT exemption on importation granted for goods needed to combat the effects of the COVID-19 outbreak during 2020 |
Please see below a table summarising 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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.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 – Dose area product meters |
2023-04-03 |
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Medical electrical equipment – Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
2023-04-03 |
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Medical electrical equipment – Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
2023-04-03 |
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Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment |
2023-04-03 |
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Medical electrical equipment – Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems |
2023-04-03 |
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Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment |
2023-04-03 |
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Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
2023-04-03 |
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Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
2023-04-03 |
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Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation |
2023-04-03 |
Standard updates
See below a table summarising the most recent ASTM standards updates:
|
Reference |
Title |
|
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
