Medical Devices | Monthly bulletin | February 2020
The United Kingdom has left the European Union
On the 1st February 2020, the United Kingdom left the European Union. At this moment there is a transition period until the end of 2020 while the UK and EU negotiate additional arrangements. The current standards and legislations for the UK and EU will continue to apply during the transition period. New legislations will take effect on the 1st January 2021.
For further general information about Brexit click here to visit the GOV.UK website.
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 |
|
17-12-2019 |
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases |
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27-12-2019 |
Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) |
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27-12-2019 |
Corrigendum to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017) |
Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):
|
Notification number |
Countries |
Title |
|
Czech Republic |
Draft act on medical devices
This draft act responds to the adoption of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices
With a view to the scope of the changes necessary at the level of national legislation, the Medical Device Regulation will be implemented by creating a new act on medical devices |
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Czech Republic |
Draft Act amending Act No 268/2014 on medical devices and on amendments to Act No 634/2004 on administrative fees, as amended, Act No 634/2004 on administrative fees, as amended and Act No 40/1995 on the regulation of advertising and on amendments to Act No 468/1991 on the operation of radio and television broadcasting, as amended, as amended
The draft act responds to the adoption of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices |
Standards updates
Please see below a table summarising the most recent standard 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 |
|||
|
Reference |
Title |
Date of Withdrawal (*) |
Supersedes |
|
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
2020-07-31 |
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
2020-07-31 |
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Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
2020-06-30 |
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Good refurbishment practices for medical imaging equipment |
2022-12-18 |
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|
IEC Standards |
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|
Reference |
Title |
Publication date |
|
Medical electrical equipment - ALL PARTS |
2020-01-06 |
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Standards updates
See below a table summarising some recent ASTM standards updates:
|
Reference |
Title |
|
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
|
|
Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants |
