Medical Devices | Q4 2020
Publications by the European Commission
Over the last few months, the European Commission has published a variety of documentation, information and publications in relation to the use of medical devices during the COVID-19 pandemic. Please see below a summary table of all recent publications:
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Official Journal of the European Union publications |
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Date |
Reference |
Title |
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21/12/2020 |
Commission Implementing Regulation (EU) 2020/2159 of 16 December 2020 amending Annex I to Council Regulation (EEC) No 2658/87 on the tariff and statistical nomenclature and on the Common Customs Tariff |
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18/12/2020 |
Commission Notice The annual Union work programme for European standardisation for 2021 |
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18/12/2020 |
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Implementation rolling plan Regulation (EU) 2017/745 and Regulation (EU) 2017/746 |
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30/10/2020 |
Commission Recommendation (EU) 2020/1595 of 28 October 2020 on COVID-19 testing strategies, including the use of rapid antigen tests |
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Please find below a table summarising the most recent technical publications on medical devices (non-exhaustive):
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Date |
Entity |
Title |
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31/08/2020 |
ANSE |
Hand sanitiser: take care to protect young children from accidentally splashing their eyes |
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01/09/2020 |
European Commission |
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01/09/2020 |
European Commission |
Guidelines on the adoption of Union-wide derogations for medical devices |
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01/09/2020 |
European Commission |
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01/09/2020 |
European Commission |
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20/10/2020 |
European Commission |
New web page with the basic information on the EUDAMED Actor registration module |
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16/12/2020 |
European Commission |
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Please see the below table summarising the most 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.
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CENELEC / CEN |
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Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020) |
2021-06-30 |
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020) |
2021-06-30 |
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Medical devices - Part 1: Application of usability engineering to medical devices |
2023-07-22 |
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Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
2023-08-26 |
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Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment |
2023-08-26 |
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Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
2023-10-07 |
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Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
2023-10-30 |
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Guidelines for masks and protective clothing manufacturing
The Ministry of Industry, Commerce and Tourism has published new documents and updates related to masks and protective clothing. See below a list of recent publications:
General
- Clarification of the different types of PPE and Sanitary Products
- List of all standards applicable to PPE and Medical Devices
Planning for the end of the Brexit transition period
UK authorities have published the following articles in relation to medical devices imported into Great Britain following the end of Brexit transition period:
For assisting and having information about the Brexit, Eurofins has produced a guide about UKCA Mark & CE Marking Changes to product compliance, certification, testing and market access which should answer many of your questions. Click here to get it.
Standards updates
See below a table summarising some recent ASTM standards updates:
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Reference |
Title |
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Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities |
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Standard Specification for Performance of Materials Used in Medical Face Masks |
