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Eurofins >> Consumer Product Testing >> Media Centre >> News >> Medical Devices | Monthly bulletin | February 2020

Medical Devices | Monthly bulletin | February 2020

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Eurofins newsflash Medical Device

 

UK

 

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.

 

Europe

 

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:

 

Date

Reference

Title

17-12-2019

C/2019/9069 final

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

27-12-2019

ST/13081/2019/INIT

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)

27-12-2019

ST/13082/2019/INIT

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)

 

Regulation proposals

 

Please find below a table summarising recent regulatory proposals made to the European Commission (Non-exhaustive):

 

Notification number

Countries

Title

2020/2/CZ

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

2020/6/CZ

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

 

Europe/International

 

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.

 

CENELEC/CEN

Reference

Title

Date of Withdrawal (*)

Supersedes

EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

2020-07-31

EN ISO 11607-1:2017

EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

2020-07-31

EN ISO 11607-2:2017

EN ISO 14971:2019

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

2020-06-30

EN ISO 14971:2012

EN IEC 63077:2019

Good refurbishment practices for medical imaging equipment

2022-12-18

 

 

IEC Standards

Reference

Title

Publication date

IEC 60601-1:2020 SER

Medical electrical equipment - ALL PARTS

2020-01-06

 

US

 

Standards updates

 

See below a table summarising some recent ASTM standards updates:

 

Reference

Title

ASTM F3208 - 19

Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

ASTM F2633 - 19

Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants