FAQ about the new PPE Regulation (EU) 2016/425

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)

No.
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))

Yes.
However, the manufacturer must declare the following:

1. that the product has not been modified and
2. that the state of the art has not changed.
3. In the case of category III products: results of the product monitoring measures conducted in accordance with Annexes VII/VIII.

However, the documents must be checked in their entirety as per the Regulation. In particular, this includes the risk assessment to be produced by the manufacturer.
If there is good reason to believe that the product has been modified, it is advisable to conduct (partial) tests as a precaution, depending on the case in hand.
(Regulation (EU)2016/425 Annex V; 7.6, Annex III; b)

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:

• “a complete description of the PPE and of its intended use”
• “an assessment of the risks against which the PPE is intended to protect” and
• “the references of the harmonised standards that have been applied for the design and manufacture of the PPE”.
• testing to verify the conformity of the PPE
• reports on the testing performed to determine the class of protection.

The following additional information is required in the “Manufacturer’s instructions and information”:

• manufacturer’s name and address and
• month and year of manufacture or period of obsolescence of the PPE.

Note:
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.

Yes.
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:

• 11A -> Module C2 (within one year) or
• 11B -> Module D (depending on period of validity, possibly >1 year)

Max. 5 years
(Regulation (EU)2016/425 Annex V; 6.1; 2nd paragraph)

1. Assessment of risks against which the PPE is intended to protect:
   This is the basis for the categorisation and classification of the PPE according to the relevant PPE standards. The NB checks and assesses the manufacturer’s risk assessment.
2. Assessment of risks that can potentially be caused by the PPE:
   the NB checks the plausibility of the manufacturer’s risk assessment. Examples:
   Health effects on wearer or environment, functional risks, risks from reasonably foreseeable use.
3. The NB ensures that the consequences of the risk assessment (residual risks) have been taken into account in the information provided by the manufacturer.

(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)

Yes.
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, 4.2.2.1; 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.:

• the risk against which the PPE is intended to protect,
• references to any applicable harmonised standards (e.g. in the Official Journal of the EU) or the
• website on which the DoC can be found.

(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
or
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))

No

One possibility is the following website where the regulation is available in all of the official languages of the EU.