The Directive 89/686 / EEC will be repealed as from April 21st 2018.
Starting from this date, SPASCIANI will manufacture and place on the market all the PPE of the respiratory tract according to Regulation (EU) 2016/425.
All the PPE manufactured by SPASCIANI are of category III, as defined in the Annex I of the Regulation.
The PPE manufactured by Spasciani will not undergo any changes, being already complex design devices for the previous Directive:
- the type-examination certificates will remain valid, as well as the harmonized reference standards for certification (in the Official Gazette 2018 /C 113/04 the harmonized standards in force for the Regulation are listed)
- Modul D Certificate – Production control, will be issued as from 21 April 2018.
The PPE will be provided with the updated instructions for use reporting the references to the Regulation.
The declaration of conformity will be:
- attached to the PPE itself or
- available for download from the website www.spasciani.com, as indicated in the instructions for use supplied with the product.
The PPE purchased and certified with the old Directive 89/686/EEC may continue to be used until the natural expiration date of the device, if and where indicated by the manufacturer.
For any request, please contact your Reseller or Spasciani Customer Service, by sending an email to firstname.lastname@example.org or calling the phone number +39 02 9695181.