Risks of Non-Compliance for PPE
Non-compliant products enter the EU Market everyday - whether manufacturer knowingly does so or due to a lack of control from the EU importer/distributor on the compliance requirements of products.
Each Competent Authorities of Member State focus on conducting systematic surveillance of products which are being made available on the market. This can include pulling products off of shelves, stopping products at customs or even deploying bots online to identify non-EU based e-commerce shops which mention that they ship to the EU Market.
In the case that a product is found to be non-complaint, the main consequences include, but are not limited to:
- Being publicly reported to the RAPEX,
- Warehousing Fees,
- Requested Withdrawal,
- Mandated Withdrawal,
- Product Recall (from end-users and/or the market),
- Complete ban on marketing of the product,
- Destruction of the product,
- Revocation of the CE Marking.
The professionalism and expertise of the appointed Authorized Representative in dealing with various Competent Authorities and handling post-market surveillance case play a vital role in the successful recovery of your brand in the EU Market.
- The Regulation: PPE Regulation (EU) 2016/425
- Path to EU Market Entry
- The Transition to the New Regulation (EU) 2016/425
- Personal Protective Equipment Directive 89/6866/EEC
- Authorized Representative
- Post-Market Surveillance
Looking to export your Personal Protective Equipment to the EU Market? Obelis can support you every step of the way.Get in touch