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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Medical Devices | Q4 2020

Medical Devices | Q4 2020

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Eurofins newsflash Medical Device

 

Regulatory news

 


 

Europe

 

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:

 

Official Journal of the European Union publications

Date

Reference

Title

21/12/2020

C/2020/9382

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

18/12/2020

2020/C 437/02

Commission Notice The annual Union work programme for European standardisation for 2021

18/12/2020

-

Implementation rolling plan Regulation (EU) 2017/745 and Regulation (EU) 2017/746

30/10/2020

C/2020/7502

Commission Recommendation (EU) 2020/1595 of 28 October 2020 on COVID-19 testing strategies, including the use of rapid antigen tests

 

Technical publications

 

Please find below a table summarising the most recent technical publications on medical devices (non-exhaustive):

 

Date

Entity

Title

31/08/2020

ANSE

Hand sanitiser: take care to protect young children from accidentally splashing their eyes

01/09/2020

European Commission

CE Factsheet for manufacturers of medical devices.

01/09/2020

European Commission

Guidelines on the adoption of Union-wide derogations for medical devices

01/09/2020

European Commission

List of COVID-19 essential Medical Devices (MDs and IVDs)

01/09/2020

European Commission

Guidance on regulatory requirements for medical face masks

Options for supporting production and/or placing on the market of medical face masks in the context of COVID-19 pandemic

20/10/2020

European Commission

New web page with the basic information on the EUDAMED Actor registration module

16/12/2020

European Commission

 

 

Standards updates

 

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(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

CENELEC / CEN

Reference

Title

Date of Withdrawal (*)

Supersedes

EN ISO 22442-1:2020

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

2021-06-30

EN ISO 22442-1:2015

EN ISO 22442-2:2020

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)

2021-06-30

EN ISO 22442-2:2015

EN 62366-1:2015/A1:2020

Medical devices - Part 1: Application of usability engineering to medical devices

2023-07-22

 

EN 60601-1-9:2008/A2:2020

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

2023-08-26

 

EN 60601-1-12:2015/A1:2020

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

 

EN IEC 60601-2-20:2020

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

2023-10-07

 

EN IEC 60601-2-22:2020

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 

EN 60601-2-22:2013

 

Spain

 

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

 

 

UK

 

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.

 

US

 

Standards updates

 

See below a table summarising some recent ASTM standards updates:

 

Reference

Title

ASTM F2407 - 20

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

ASTM F2100 - 20

Standard Specification for Performance of Materials Used in Medical Face Masks