- Latest available (Revised)
- Original (As adopted by EU)
Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title
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)
You are here:
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Changes over time for: Article 32
Changes to legislation:
There are outstanding changes not yet made to Regulation (EU) 2016/425 of the European Parliament and of the Council. Any changes that have already been made to the legislation appear in the content and are referenced with annotations.
Changes to Legislation
Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to the whole legislation item and associated provisions
- Art. 3(2) words substituted by S.I. 2019/696 Sch. 35 para. 3(4)(a) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(a) substituted immediately before IP completion day by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4))
- Art. 3(3) words substituted by S.I. 2019/696 Sch. 35 para. 3(4)(a) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(a) substituted immediately before IP completion day by S.I. 2020/1460, reg. 1(4), Sch. 3 para. 24(4))
- Art. 3(5) substituted by S.I. 2019/696 Sch. 35 para. 3(4)(b) (This amendment not applied to legislation.gov.uk. Sch. 35 para. 3(4)(b) omitted immediately before IP completion day by virtue of S.I. 2020/1460, reg. 1(4), Sch. 3 para. 3)
- Art. 3(5) words substituted in earlier amending provision S.I. 2019/696, Sch. 35 para. 3(4)(b) by S.I. 2020/852 reg. 4(2) Sch. 1 para. 1(u)(ii) (This amendment not applied to legislation.gov.uk. Sch. 1 para. 1(u)(ii) omitted immediately before it comes into force by virtue of S.I. 2020/1460, regs. 1(3), Sch. 4 para. 1(3))
- Art. 24(2A) inserted by S.I. 2024/504 reg. 17(b)
Article 32U.K.Operational obligations of [F1approved] bodies
1.[F2Approved] bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annexes V, VII and VIII.
[F31A.Subject to the terms of its appointment an approved body must carry out the conformity assessment activities and procedures, in respect of which—
(a)the body's approval was given under Article 21; or
(b)the body's notification as a notified body was made.]
2.Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Conformity assessment bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the PPE technology in question and the mass or serial nature of the production process.
In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the PPE with the requirements of this Regulation.
3.Where [F4an approved] body finds that the essential health and safety requirements set out in Annex II or the corresponding [F5designated] standards or other technical specifications have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.
4.Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, [F6an approved] body finds that a PPE no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision if necessary.
5.Where corrective measures are not taken or do not have the required effect, the [F7approved] body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.
Textual Amendments
F1Word in Art. 32 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(30)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Word in Art. 32(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(30)(b); 2020 c. 1, Sch. 5 para. 1(1)
F3Art. 32(1A) inserted (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(30)(c); 2020 c. 1, Sch. 5 para. 1(1)
F4Words in Art. 32(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(30)(d); 2020 c. 1, Sch. 5 para. 1(1)
F5Word in Art. 32(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(30)(e); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 32(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(30)(d); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in Art. 32(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(30)(a); 2020 c. 1, Sch. 5 para. 1(1)
Options/Help
Print Options
PrintThe Whole Regulation
PrintThe Whole Chapter
PrintThis Article only
You have chosen to open the Whole Regulation
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
You have chosen to open Schedules only
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Legislation is available in different versions:
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
See additional information alongside the content
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.
The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.
For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.