Latest Update on the PPE Regulation
The Personal Protective Equipment Regulation (EU) 2016/425
In January 2018 we issued a bulletin on the transition from the PPE Directive 89/686/EEC to the PPE Regulation. Now that the Regulation is in force, BTTG™ are able to offer an update on the progress of the transition.
- From 21st April 2018, PPE can be CE marked and placed on the market using the Regulation.
- PPE can still be CE marked and placed on the market (produced and sold, or imported into the EU) using the PPE Directive until 21st April 2019.
- From 21st April 2019, all PPE placed on the market must be CE marked using the Regulation.
Complying with the Regulation
- Update Technical Documentation
- Risk Assessment to be included
- Essential Health and Safety Requirements: listed, gaps identified & filled
- Information to users and product marking revised
- Category II PPE: implement Module C (Internal production control)
- Category III PPE: implement Module C2 / D
- Draw up an EU Declaration of Conformity
- Using Module B Certificate
- Using a valid PPE Directive Article 10 Certificate
Validity of PPE Directive Certificates
Article 47(2) of the Regulations states:
“EC type-examination certificates and approval decisions issued under Directive 89/686/EEC shall remain valid until 21 April 2023 unless they expire before that date.”
The EU commission document (Ref. Ares(2017)5995514 - 07/12/2017) clarifies the meaning of this article. The document can be found at: http://ec.europa.eu/docsroom/documents/26782
According to the document, existing PPE Directive Article 10 certificates remain valid and can be used to draw up an EU Declaration of Conformity until the certificate expires or the 21st April 2023, whichever comes first.
Existing Article 10 certificates can NOT be used where:
- The certificate is based on a superseded standard (the generally acknowledged state of the art has changed).
- The manufacture and / or the product design has changed.
- One or more Essential Health & Safety Requirements have substantially changed, requiring a higher level of protection.
In this case, the Manufacturer must obtain a Module B Certificate to the PPE Regulation.
Updating PPE Directive Certificates
- Confirmation that there has been no modification to the approved type, including materials, sub-components or sub-assemblies
- Risk Assessment
- List of Essential Health and Safety Requirements
- Updated User Information
- Details of how the Declaration of Conformity will be supplied
- Description of the means used during production to ensure conformity (quality plan / test schedule)
- When updating standards, test data to fill any gaps with the new standard
- For all updates, test data to verify conformance, such as:
- Data from manufacturers regular internal or external testing
- Article 11A test data
- Updated product or material testing (within 5 years)