Post-Market Surveillance for PPE
It is the responsibility of the manufacturer to continue to collect information related to use of their products after they have been made available to consumers as well as to ensure that they continue to be compliant as the legislation applicable to their products evolves.
Post-Marketing surveillance activities include, but are not limited to:
- 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.
Working with a professional Authorized Representative will help to ensure that the necessary actions are taken to ensure continued compliance and proper post-market surveillance.
- 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
- Risks of Non-Compliance
Looking to export your Personal Protective Equipment to the EU Market? Obelis can support you every step of the way.Get in touch