About the EU Commission Recommendation (EU) 2021/1433 for PPE

The EU Commission recently issued Commission Recommendation (EU) 2021/1433 on conformity assessment and market surveillance within the context of the Covid-19 threat. This relates to procedures for personal protective equipment (PPE), especially face masks, but also gloves, protective coveralls and eyewear protection.

It is vital that manufacturers or distributors who placed PPE on the market using the 2020/403 understand the changes and act to ensure they are following the correct legislation.

Read the EU Recommendation now >

What has changed?

This Recommendation (2021/1433) relates specifically to the EU Commission Recommendation (EU) 2020/403 for PPE, which was issued on March 13, 2020 to provide a temporary easement process for the CE certification of personal protective equipment (PPE) to be used in healthcare to fight Covid-19.

This latest Recommendation (2021/1433), in essence brings about an end to this easement (according to the below timelines) and reiterates that all PPE placed on the European market after these dates must obtain full certification to the PPE Regulation. 

Key dates

  • From October 1, 2021 all PPE placed onto the European market must be certified fully to the PPE Regulation 2016/425. PPE placed on the market using the 2020/403 easement cannot be placed onto the market after October 1, 2021.
  • PPE using the 2020/403 easement that is already in the market can only be made available until May 31, 2022.
  • The only situation where PPE using the 2020/403 easement can continue to be used after May 31, 2022 is where existing stock is used by healthcare workers, first responders and other personnel involved in efforts to contain the virus.
  • After July 31, 2022, no PPE using the 2020/403 easement can be used in any circumstances

What do I need to do now?

BSI will formally cancel any certificates issued under the 2020/403 Recommendation that are still valid on 31 May 2022, and any certificates issued under the 2020/403 Recommendation that expire before 31 May 2022 will not be renewed.

Should you wish to continue to place PPE on the European market after these dates, you must transfer to and obtain full certification to the PPE Regulation. If you would like to apply to this, please do get in touch and we will be happy to assist you.

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