On 21 April 2018; this applies, in particular, to the “Obligations of economic operators” described in Chapter II.
(Regulation (EU) 2016/425 Art. 48 (2) and Chapter II; Art. 8 to 13)
According to the Regulation, “Member States shall not impede the making available on the market” of PPE that complies with Directive 89/686/EEC and was placed on the market prior to 21 April 2019.
(Regulation (EU) 2016/425, Art. 47 (1))
However, the manufacturer must declare the following:
Re-assessment with (additional) testing that covers the modification.
(Regulation (EU)2016/425 Annex V; 7.2)
Re-assessment with (additional) testing that covers the change.
(List of harmonised standards)
The regulation requires the following additional information to be given in the technical documentation:
The following additional information is required in the “Manufacturer’s instructions and information”:
Additional descriptions are required for PPE that is adapted to fit an individual user.
Regulation (EU)2016/425 Annex III and Annex V (Module B) 2 and 4 a), Annex III, a), Annex III, b), Annex III, f), Annex II, 1.4 b) and c), Annex II, 1.4
A blanket rule is not possible. This aspect must be decided by the certifying person on a case-by-case basis.
The procedure is the same as the current procedure for accepting a certificate issued by another body, including verification of compliance with the requirements of the regulation.
It is beneficial if all the certification and testing bodies concerned are involved in the acceptance process. This is also possible during the period of validity of the original certificate that is to be revoked.
(ZEK-GB-2012-01 rev. 1, 28.09.2016)
Yes. The certificate and test report for the last monitoring measure in accordance with Art. 11A/11B must be provided.
Upon expiry, they have to be converted as follows:
Max. 5 years
(Regulation (EU)2016/425 Annex V; 6.1; 2nd paragraph)
(Regulation (EU)2016/425 Annex I and Annex III b, Annex II, 1.4, Annex II, preliminary remark 4,m Annex II, preliminary remark 5)
The name and postal address of the certificate holder must be legibly marked on the PPE if technically possible or, if not, on the packaging or the instructions.
(Optional envelope pictogram; type height at least 5 mm, as with the CE mark)
(Regulation (EU)2016/425 Annex II 2.12; Article 8 (6); Blue Guide, 18.104.22.168; Article 30 of Regulation (EG)765/2008)
There is no obligation to provide the NB with the EU declaration of conformity (document). The NB checks the DoC (draft) provided in the instructions and/or whether the instructions indicate where the DoC is to be found.
(Regulation (EU)2016/425 Annex VII (Module C2), 6.2; Annex VIII (Module D), 5.2; Blue Guide 2016, Annex IV, Module B, “Manufacturer” column)
The additional aspects required by the regulation, e.g.:
(Regulation (EU) 2016/425, Annex II, 1.4. References to the standards and the website for the DoC are not required if they accompany the PPE.)
An evaluation report must be produced but it does not have to be part (e.g. annex) of the type-examination certificate
(Regulation (EU)2016/425 Annex V (Module B), 5)
They have to be dealt with at the same time and in accordance with the same rules as the “original certificate”.
Same rules as for original certificate.
Note on the certificate stating the change to Cat. III with an obligation to perform monitoring measures.
(Note: This is only possible with the new type-examination certificate).
Supervised product checks in accordance with Module C2 within one year of the Cat. III certificate being issued
surveillance in accordance with Module D after the Cat. III certificate (type-examination certificate) is issued but before production begins.
(Regulation (EU) 2016/425 Annex V (Module B), 6.2. k), Annex VII (Module C2), 4.2, Art. 19 c))
One possibility is the following website where the regulation is available in all of the official languages of the EU.