Authorized Representative for PPE
At the discretion of the manufacturer, an Authorized Representative may be appointed by written mandate to undertake such activities as:
- Staying up-to-date on new requirements or legislative changes,
- Continual updating of the technical file as modifications are made to the product,
- Reporting of any incidents related to the product use,
- Removal of non-compliant batches from EU economics operators and end-user,
- Keeping technical file available for 10 years after the last batch entered the EU market.
The Authorized Representative should be clearly identified on the packaging to ensure efficient communication between end-users, Competent Authorities, economic operators with regard to the product(s) compliance.
- 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
- Post-Market Surveillance
- Risks of Non-Compliance
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