The European Commission has published a document of ‘Frequently Asked Questions’ to provide guidance on the application of the new PPE Regulation. The document is attached. This is initial guidance, and the Commission plans to publish a new version of the ‘PPE Guidelines’ for the Regulation, similar to the one we already have for the Directive, by April 2018.
This FAQ document does not resolve the debate on the date by which all EC Type Examination Certificates need to be replaced by new EU Type Examination Certificates. The Commission is currently in consultation with all member states, whose positions are varying between ‘all certificates must be renewed by April 2019’ right through to ‘for valid EC Certificates no renewal is necessary until April 2023, even for products moving from Cat II to Cat III’.
Please remember that the text in the Regulation which gives rise to this debate, Article 47, paragraph 2, refers only to certification of products, not the products themselves. The PPE Directive will be repealed in April 2018, with one further year allowed when products can comply to either the Directive or Regulation, and then from 21 April 2019 all PPE placed on the market (by the manufacturer, which includes any economic operator with manufacturer’s obligations) must comply with the requirements of the Regulation. Products complying with the Directive that are already on the market (i.e. in the distribution chain) can continue to be sold.
In the vast majority of instances where little has changed, all that will be required to bring a product which complies with the Directive into compliance with the Regulation will be minor changes to the product markings, the user instructions (UI’s), and the Declaration of Conformity (DoC), plus an updating of the Technical File. These changes will need to be made by April 2019. The responsibility falls on the manufacturer to review the requirements of the Regulation and then take the necessary action to bring his products into compliance, including consultation with his Notified Body making them aware of the changes made. However our current estimate is that throughout Europe there are c.275,000 certificates that will require renewal, and the workload this represents makes it unlikely that all new certificates will be issued in time. There is real potential that products will be made compliant ‘with certificates to follow’.
Where any substantial change to the standard or product is found then a new certificate will be required by April 2019. The current understanding is that this is likely to include products changing from Cat II to Cat III.
BSIF continue to work through ESF to lobby the European Commission for clarity in areas that still need it. We are grateful to ESF for the second document attached, a flowchart depicting a pathway for compliance. This has been submitted to the Commission and is acknowledged by them as a potential way forward.
We will keep you informed as more information is received.