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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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There are currently no known outstanding effects for the Regulation (EU) 2016/425 of the European Parliament and of the Council, Division CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS.
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Textual Amendments
F1Word in Annex 8 para. 1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PPE concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.
Textual Amendments
F2Word in Annex 8 para. 3.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
the address of the manufacturer's premises where the audits can be carried out;
a written declaration that the same application has not been lodged with any other [F2approved] body;
the identification of the PPE concerned;
the documentation concerning the quality system.
Where the chosen body is not the body that has carried out the F3... type-examination, the application shall also include the following:
Textual Amendments
F3Word in Annex 8 para. 3.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(b); 2020 c. 1, Sch. 5 para. 1(1)
the technical documentation of the PPE described in Annex III;
a copy of the F3... type-examination certificate.
Textual Amendments
F4Word in Annex 8 para. 3.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
The quality system documentation shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned; and
the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
Textual Amendments
F5Word in Annex 8 para. 3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant [F6designated] standard.
Textual Amendments
F6Word in Annex 8 para. 3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(e); 2020 c. 1, Sch. 5 para. 1(1)
In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturer's ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements.
The result of that assessment shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.
Textual Amendments
F7Word in Annex 8 para. 3.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)
The [F7approved] body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
Textual Amendments
F8Word in Annex 8 para. 3.6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)
F9Word in Annex 8 para. 3.6 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F11Word in Annex 8 para. 4.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
the quality system documentation;
the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned.
Textual Amendments
F12Word in Annex 8 para. 4.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F13Word in Annex 8 para. 4.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F10Word in Annex 8 para. 4 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F16Word in Annex 8 para. 5.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(f); 2020 c. 1, Sch. 5 para. 1(1)
F17Word in Annex 8 para. 5.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
F18Word in Annex 8 para. 5.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F19Word in Annex 8 para. 5.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(b); 2020 c. 1, Sch. 5 para. 1(1)
F20Words in Annex 8 para. 5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(g)(i); 2020 c. 1, Sch. 5 para. 1(1)
A copy of the F19... declaration of conformity shall be made available to the [F21enforcement authority] upon request.
Textual Amendments
F21Words in Annex 8 para. 5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F14Word in Annex 8 para. 5 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(f); 2020 c. 1, Sch. 5 para. 1(1)
F15Word in Annex 8 para. 5 heading omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F22Words in Annex 8 para. 6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(h); 2020 c. 1, Sch. 5 para. 1(1)
the documentation referred to in point 3.1;
the information related to the change referred to in point 3.5, as approved;
the decisions and reports of the [F23approved] body referred to in points 3.5, 4.3 and 4.4.
Textual Amendments
F23Word in Annex 8 para. 6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F24Word in Annex 8 para. 7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)
F25Words in Annex 8 para. 7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(51)(i); 2020 c. 1, Sch. 5 para. 1(1)
The [F24approved] body shall inform the other [F24approved] bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of such quality system approvals which it has issued.
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
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