Personal Protective Equipment Regulation

Personal Protective Equipment

The new PPE Regulation

The new PPE Regulation
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Personal Protective Equipment
Personal Protective Equipment
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The new PPE Regulation

The Personal Protective Equipment (PPE) Directive 89/686/EEC was adopted by the European Council in 1989 and since that time it has largely remained unchanged. As it’s now over 20 years old, it was in need of updating to reflect current technologies and processes of bringing PPE to the market. The new Regulation has been published. With the new changes, we will keep you updated and we will support you through the transition. We will provide you with guidelines, useful information and training to help you make this as smooth as possible.

At a glance

What are the key changes of the new Regulation?

  • Moving hearing protection from Category II to Category III PPE
  • Moving life jackets from Category II to Category III PPE
  • Issuing a Declaration of Conformity with each PPE or at least a link to where it can be obtained
  • A compulsory maximum five-year certificate validity
  • Responsibilities outlined for importers and distributors
  • Bespoke PPE covered in the Regulation.

Essential information about the EU Commission Recommendation (EU) 2020/403 of 13 March, 2020

What the European Commission's recommendation on conformity assessment and market surveillance procedures means for manufacturers of face masks and other PPE.

In the context of the COVID-19 pandemic the EU has published a recommendation on conformity assessment and market surveillance procedures for Personal Protective Equipment (PPE), especially face masks, but also gloves, protective coveralls and eyewear protection.
As a Notified Body for the PPE Regulation, BSI is committed to working to support the Commission’s recommendation to ensure that adequate protection is swiftly made available to those who need it most. Our experts have reviewed this recommendation to understand what it could mean for our clients.
The information below contains some key points covered by the recommendation.

Why has the Commission published this recommendation?
Due to the unprecedented levels of demand for PPE in response to the COVID-19 pandemic the European Commission is encouraging Notified Bodies to process applications for CE marking swiftly and to consider non-harmonised standards for certification. This guidance has been given to enable more product to be placed on the market in the EU more quickly. It also aims to reduce the risk of medical professionals and first responders, not having access to the correct or to sufficient PPE.

What does the recommendation say?
For PPE products that are manufactured following technical solutions other than harmonised standards, the World Health organization (WHO) recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions. However, this is only permitted if the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements which are contained in the PPE Regulation (EU) 2016/425.

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

PPE Regulation webinars

If you are a new supplier or someone who is looking to market Personal Protective Equipment in the healthcare industry, you need to be aware of the relevant Regulations and Standards before going into market ensuring that it is fit for purpose and safe for use by healthcare workers. (See our guide here for more information on the process).

In response to the demand for more information and to support those in the supply and manufacturing industry of PPE, we will be running a series of webinars.

Join our experts to find out how to stay on top of the regulatory changes in the current market conditions and the obligations from you as a manufacturer or supplier of PPE.