Schweizerische Vereinigung für Qualitäts- und Managementsysteme

🇨🇭 Switzerland · Zollikofen Active

www.sqs.ch

Designations

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

Conformity assessment annexesAnnex V, Annex II, Annex VI

Designated since2007-09-13

Full scope text from the register

Annexes

Annex V, Annex II, Annex VI

Procedures

Full quality assurance system, Production quality assurance, Product quality assurance

Products

dental equipment and instruments
bandages and dressings
disinfection and sterilization equipment
orthopaedic implants
Single-use products
ophtalmological devices
functional implants
dental equipment
dental implants
suture material and clamps
non-energized medical instrumentation
prostheses and rehabilitation devices
medical gas supply system and parts (units) thereof
dental materials
surgical equipment and ancillary surgical equipment
reusable non-active medical instruments
equipment for extracorporeal circuits, infusions and haemophoresis excluding heart-lung machines
imaging equipment
anaesthetic, orthopaedic and rehabilitation devices
Active medical devices
Non-active medical devices
with ionizing radiation and with non-ionizing radiation
soft tissue implants
disinfectants and antiseptics

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=1250

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.