CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS

🇪🇸 Spain · MADRID Active

www.certificaps.gob.es

Designations

MDR Medical devices · Regulation (EU) 2017/745 Active

Conformity assessment annexesAnnex 5, Annex 3, Annex 4, Annex 2

Designated since2006-04-09

Full scope text from the register

Annexes

Annex 5, Annex 3, Annex 4, Annex 2

Procedures

EC declaration of conformity (complete quality assurance system), EC verification, EC type-examination, EC declaration of conformity to type (assurance of production quality)

Products

All active implantable medical devices

Source: EU Single Market Compliance Space (SMCS), retrieved 2026-06-23.
https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/free-search?text=0318

This page is an informational mirror of the official register. It is not affiliated with the European Commission. Always verify the current designation and scope against the official SMCS record before relying on it.