Dental Austral
Piton Saint-Leu, France
Réunion-based supplier of dental supplies and equipment with maintenance and advice for professionals.
Business types in Piton Saint-Leu
Regulation in France
France is in the EU / EEA, so the EU framework applies.
Regulator: European Commission (DG SANTE) with national competent authorities of EU/EEA Member States
Two EU regulations govern medical devices and IVDs in the EU/EEA; devices need CE marking after the conformity assessment route set by their risk class.
From the sourced EU MDR / IVDR entry, checked 29 October 2026. General information, not legal advice. Requirements for France · All medical certifications
Frequently asked questions
Does a French medical device company need a person responsible for regulatory compliance (PRRC)?
Yes, if it is a manufacturer or an EU authorized representative. Article 15 of the EU MDR requires manufacturers to have at least one person responsible for regulatory compliance (PRRC) within their organization. Micro and small enterprises may instead have such a person permanently and continuously at their disposal, for example through an external arrangement. Authorized representatives also need a PRRC available.
The PRRC oversees conformity checks before release, technical documentation, post-market surveillance and vigilance reporting. Importers and distributors that only resell do not need one. When assessing a French manufacturer on the France country page, ask who acts as PRRC.
How can I check a French supplier’s notified body certificate?
Ask for the certificate itself, not just the CE logo on a catalog, and check:
- the notified body's name and four-digit number, which should appear in the European Commission's NANDO database as designated under the MDR for the relevant device codes;
- that the certificate covers the exact device and the correct conformity route (for reusable Class Ir instruments, the reuse aspects);
- validity dates and any suspension;
- that the same number appears next to the CE mark on the label.
Notified body certificates are also recorded in EUDAMED's certificates module, which has been mandatory since 28 May 2026. A certificate is device-specific, not a company-wide "CE certificate". See the medical certifications page.
What should I check when sourcing from a French distributor rather than a manufacturer?
Article 14 of the EU MDR requires distributors to verify, before supplying a device, that it is CE marked, has a Declaration of Conformity, carries the required labeling and instructions, and shows the importer's details where it was imported. Distributors must also keep complaint and traceability records.
From a buyer's side, ask a French distributor for the legal manufacturer's name, the EU authorized representative (if the maker is outside the EU), the notified body certificate for Class Ir or higher devices, and the device's UDI. The directory currently lists more than 25 companies in France, with a city page for La Ciotat. Listings are self-described; see the France country page.