Europe has decided to strengthen its requirements in the trade of medical devices on its territories by releasing a new regulation framing the market of medical Devices: RDM 2017 / 145.
To be able to sell Medical Devices on the Europeans territories, non-EU companies must have an Authorised Representative located in Europe. Tasks of the representative are described in the article 11 of the RDM 2017/745.
The Purpose of ETTSONS is to support you in the labyrinth of regulatory requirements to be able to continue your sales activities on the European territories.
Thanks to our team of experts, including the qualified Person Responsible for Regulatory Compliance (PRRC) Ettsons is registered on the EUDAMED database under the Single Registration Number AR-FR-00000145.
The EAR requirement will no longer be an obstacle for your company.
ETTSONS is committed not only to represent you on the European territory, but also to support your regulatory activities.
