The Transition to the New Regulation (EU) 2016/425
The PPE Directive 89/686/EEC is repealed with effect from 21 April 2018. The PPE Regulation (EU) 2016/425 shall apply from 21 April 2018. As of 21 April 2018, manufacturers can place PPE on the European market which are compliant with the PPE regulation.
The article 47 of Regulation 2016/425 foresees a specific transitional regime for PPE:
- PPE designed and manufactured in accordance with Directive 89/686/EEC can still be placed on the market until 21 April 2019, and in principle EC type-examination certificates in accordance with Directive 89/686/EEC can be issued until the end of the transitional period, unless the classification of the product and/or the essential safety requirements applicable to it have changed (in the new Regulation).
- PPE may be placed on the market after 21 April 2019 and no later than 21 April 2023 on the basis of an EC type-examination certificate and/or an approval decision in accordance with the PPE Directive. This is not applicable in the following cases:
1) Higher classification in the Regulation (after 21 April 2019),
2) Updated version of the Harmonized Standard may result in a non-compliance of the product with the new Regulation,
3) Change in design and/or manufacture of the PPE.
- The Regulation: PPE Regulation (EU) 2016/425
- Path to EU Market Entry
- Personal Protective Equipment Directive 89/6866/EEC
- Authorized Representative
- Post-Market Surveillance
- Risks of Non-Compliance
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