Eckermann
Almoradí, Spain
Spanish manufacturer of dental implants based in Almoradí, Alicante, with over 25 years of experience.
Business types in Almoradí
Regulation in Spain
Spain 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 Spain · All medical certifications
Frequently asked questions
What does a Spanish company take on when it acts as EU authorized representative?
A non-EU manufacturer must designate a single EU authorized representative by written mandate (Article 11 of the EU MDR), and an EU company, for example one in Spain, can take on that role. The authorized representative must:
- check that the Declaration of Conformity and technical documentation exist and keep copies available to authorities;
- register in EUDAMED and cooperate on corrective actions and incidents;
- have a PRRC available;
- end the mandate and inform the authority if the manufacturer breaches its obligations.
The authorized representative's details appear on the labeling. It is not automatically the importer or distributor. Browse Spanish companies on the Spain country page.