Main requirements of the Personal Protective Equipment Regulations (EU) 2016/425:

This Regulation lays down requirements for the design and manufacture of personal protective equipment (PPE) which is to be made available on the market, in order to ensure protection of the health and safety of users and establish rules on the free movement of PPE in the Union.

Definition of PPE:

  • Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety;
  • Interchangeable components for equipment referred to in point (a) which are essential for its protective function;
  • Connexion systems for equipment referred to in point (a) that are not held or worn by a person, that are designed to connect that equipment to an external device or to a reliable anchorage point, that are not designed to be permanently fixed and that do not require fastening works before use;

There are some exclusions listed in the Regulations:

  • Specifically designed for use by the armed forces or in the maintenance of law and order;
  • Designed to be used for self-defence, with the exception of PPE intended for sporting activities;
  • Designed for private use to protect against: (i) atmospheric conditions that are not of an extreme nature, (ii) damp and water during dishwashing;
  • For exclusive use on seagoing vessels or aircraft that are subject to the relevant international treaties applicable in Member States;
  • For head, face or eye protection of users, that is covered by Regulation No 22 of the United Nations Economic Commission for Europe on uniform provisions concerning the approval of protective helmets and their visors for drivers and passengers of motorcycles and mopeds.

Please refer to the personal protective equipment regulations for detailed requirements

Services that we offer as a notified body

EU Type examination Module B:
CTI-CEM can provide full EC Type Examination and issue a certificate confirming that it meets the requirements of the Personal Protective Equipment Regulations. This is a requirement if PPE is listed in Annex IV and is not manufactured in accordance with relevant harmonised standards.  It is also available for other PPE where third party certification is desired.

Conformity to type based on internal production control plus supervised product checks at random intervals. Module C2:
The company shall carry out product checks in accordance with annex VII of the PPE Regulation (EU) 2016-425 in order to verify the homogeneity of production and the conformity of the PPE with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements.

CTI-CEM will arrange for equipment to be tested to ensure that it conforms to the requirements of the Personal Protective Equipment Regulations (EU) 2016/425.

Technical File Lodging:
Where the regulations are applied in full, the Technical File must be lodged with a Notified Body.  CTI-CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.

Technical documentation
Upon successful assessment, Personal Protective Equipment Regulations (EU) 2016/425 requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Regulation.

The technical file should comprise:

• a detailed documentation on the construction of the PPE,
• test results,
• other elements as described in Annex VII, A(a).

Also, the file must contain a copy of the EC declaration of conformity.

The manufacturer must also provide documents for series production and internal measures that will be implemented to ensure that the PPE remains in conformity with the provisions of this Regulation (Annex VII, A (b)).

The manufacturer must carry out the necessary tests. The relevant reports and results shall be included in the technical file.

The manufacturer or his authorised representative is requested to keep copies of the technical documentation for a period of 10 years after the last product was placed into the market.

How we can help

CTI-CEM International are a notified body for the Personal Protective Equipment Regulations and can provide assistance with certification.

Contact us