BSI Group Deutschland GmbH

🇩🇪 Germany · Frankfurt am Main Active

www.bsigroup.de

Designations

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

Conformity assessment annexesAnnex II, Annex IV, Annex V, Annex III, Annex VI

Designated since2006-04-09

Full scope text from the register

Annexes

Annex II, Annex IV, Annex V, Annex III, Annex VI

Procedures

Production quality assurance, EC type-examination, EC verification, Product quality assurance, Full quality assurance system

Products

dental devices
All active medical devices (except for devices for hyperbaric therapy)
reusable non-active medical instruments
bandages and dressings
Non-active medical devices, except Class III 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=0535

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.