Latest Update on the PPE Regulation

The Personal Protective Equipment Regulation (EU) 2016/425

LASTEST UPDATE

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.

In Summary:

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
OR
- 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The certificate is based on a superseded standard (the generally acknowledged state of the art has changed).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

In the three cases listed above, Article 10 certificates must be updated to Module B, most typically when the standard has been superseded. Manufacturers are also voluntarily updating their certificates to the Regulation.

In order to update certificates, BTTG® require the following:

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)

If not available, verification testing will be required.

Category III PPE

For manufacturers using Article 11A, the change to Module C2 will happen at the next selection. There is no practical difference between the two procedures.

Article 11A approvals remain valid during their validity, so can be used when drawing up the EU Declaration of Conformity.

For manufacturers using Article 11B, audits are now being conducted according to Module D. Where the manufacturer complies with the requirements of the Regulation, and has updated their technical documentation, a Module D Certificate will be issued. Where this is not the case, as long as the Manufacturer complies with the Regulation by 21st April 2019, the existing Article 11B certificate can be used to draw up the EU Declaration of Conformity.