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Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
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CHAPTER VI MARKET SURVEILLANCE AND CONTROL OF PPE ENTERING THE UNITED KINGDOM MARKET
ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
1. The essential health and safety requirements laid down in this...
2. Obligations related to essential health and safety requirements apply only...
3. The essential health and safety requirements are to be interpreted...
4. The manufacturer shall carry out a risk assessment in order...
5. When designing and manufacturing the PPE, and when drafting the...
1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE
... TYPE-EXAMINATION (Module B)
1. ... Type-examination is the part of a conformity assessment procedure...
2. ... Type-examination shall be carried out by assessment of the...
7. Review of the ... type-examination certificate
7.1. The approved body shall keep itself apprised of any changes...
7.2. The manufacturer shall inform the approved body that holds the...
7.3. The manufacturer shall ensure that the PPE continues to fulfil...
7.4. The manufacturer shall ask the approved body to review the...
7.5. The approved body shall examine the PPE type and, where...
7.6. Where the conditions referred to in points (a) and (b) of point 7.4...
7.7. If, following the review, the approved body concludes that the...
8. Each approved body shall inform the Secretary of State concerning...
9. The manufacturer shall keep a copy of the ... type-examination...
10. The manufacturer's authorised representative may lodge the application referred to...
1. Conformity to type based on internal production control plus supervised...
3. Application for supervised product checks at random intervals
4.1. The approved body shall carry out product checks in order...
4.2. The product checks shall be carried out at least once...
4.3. An adequate statistical sample of the manufactured PPE shall be...
4.4. Where the approved body referred to in point 3 is not...
4.5. The acceptance sampling procedure to be applied is intended to...
4.6. If the examination and testing reveal that the production is...
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (Module D)
1. Conformity to type based on quality assurance of the production...
3.1. The manufacturer shall lodge an application for assessment of his...
3.3. The approved body shall assess the quality system to determine...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the approved body that has approved...
3.6. The approved body shall authorise the manufacturer to affix the...
4. Surveillance under the responsibility of the approved body
6. The manufacturer shall, for 10 years after the PPE has been...
7. The approved body shall inform the Secretary of State of...
... DECLARATION OF CONFORMITY No …
2. Name and address of the manufacturer and, where applicable, his...
3. This declaration of conformity is issued under the sole responsibility...
4. Object of the declaration (identification of PPE allowing traceability; where...
6. References to the relevant designated standards used, including the date...
7. Where applicable, the approved body … (name, number) … performed...
8. Where applicable, the PPE is subject to the conformity assessment...
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