Regulation(EU) 2016/425 :-
- Fall protection products for individual & multiple users
- Head protection
- Protective wears
- PPE for Medical use ( Protective coveralls, masks, above neck face & eye protection, etc)
- Foot Protection
We are DRDO Certified Manufactures of PPE Suite
PPE Regulation (EU) 2016/425 has replaced the PPE Directive 89/686/EEC in April 2018, covers the manufacturing of PPE to ensure the highest level of protection. The CE mark on PPE is evidence that the PPE Complies with relevant standards and is safe for use.
Our expertise in assessing Personal Protective Equipment manufacturers around the world to test and certify their products. Our experienced Certification team can assist manufacturers in choosing the correct procedures and test methods for their products, and provide guidance on aspects of the type-examination such as Technical File content, Labelling, and User Information.
PPE Category wise Requirement:
| Category |
Requirement |
Applicable Modules |
| Category I |
Internal Production Control a process that requires the development of a technical file that includes the manufacturer’s Declaration of Conformity. |
Internal production control (module A) |
| Category II |
EU-type examination by a Notified Body. |
EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) |
| Category III |
EU Type Examination certificate and ongoing assessment of compliance.
Audit the manufacturing site annually to ensure that quality management systems are in place. |
EU type-examination (module B) set out in Annex V, and either of the following:
· conformity to type based on internal production control plus supervised product checks at random intervals (module C2);
· conformity to type based on quality assurance of the production process (module D) |
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