St ubli MDR Electrical Medical Devices User Manual
- May 15, 2024
- ST UBLI
Table of Contents
St ubli MDR Electrical Medical Devices
Product Information
Specifications
- Regulation: EU 2017/745 (MDR)
- Intended Purpose : For human beings for specific medical purposes
- Safety Requirements: Annex I of the MDR
- Classification: Annex VIII based on intended purpose and risks
- Hazardous Substances: Restricted to 0.1% (w/w) CMR category 1A or 1B
Product Usage Instructions
- Installation
- Properly install the medical device according to the manufacturer’s instructions.
- Maintenance:
- Regular maintenance is essential to ensure proper functioning and safety. Follow maintenance guidelines provided by the manufacturer.
- Intended Use:
- Use the medical device only for its intended purpose as specified by the manufacturer.
- Safety Precautions:
- Adhere to all safety precautions mentioned in the user manual to prevent accidents and ensure user safety.
INSTRUCTION
Medical devices are subject to Regulation (EU) 2017/745 (MDR). The affected devices must be properly installed, maintained, and used in accordance with its intended purpose. They shall meet the general safety and performance requirements set out in Annex I of the MDR unless otherwise described in Article 5 (5).
“Medical Devices” means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information using in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.
Medical devices need to be registered according to:
- Article 25 – Identification within the supply chain
- Article 26 – Medical devices nomenclature
- Article 27 – Unique Device Identification System
- Article 28 – UDI database
- Article 29 – Registration of devices
- Article 30 – Electronic system for registration of economic operators
- Article 31 – Registration of manufacturers, authorized representatives, and importers
- Article 32 – Summary of safety and clinical performance
- Article 33 – European database on medical devices
- Article 34 – Functionality of Eudamed
Medical devices must be classified as described in Annex VIII according to the intended purpose and the inherent risks. Depending on the classification the conformity assessment is based on an appropriate quality management system and assessment of technical documentation, type examination or product conformity verification.
For relevant devices there are requirements about hazardous substances regarding design and manufacture listed in Annex I Chapter II, restricting the concentration to 0,1 % (w/w) of carcinogenic, mutagenic or toxic to reproduction (CMR), of category 1A or 1B, per Part 3 of Annex VI to Regulation (EC) No 1272/2008.
FAQ
Frequently Asked Questions
- Q: How should I register my medical device?
- A: Medical devices need to be registered according to the regulations specified in Annex VIII based on intended purpose and risks.
- Q: What are the requirements for hazardous substances?
- A: Hazardous substances are restricted to 0.1% (w/w) of CMR category 1A or 1B as per Part 3 of Annex VI to Regulation (EC) No 1272/2008.
Stäubli Electrical Connectors AG Stockbrunnenrain 8
4123 Allschwil/Switzerland
Tel. +41 61 306 55 55
Fax +41 61 306 55 56
ec.ch@staubli.com
www.staubli.com/electrical
UBS AG 4002 Basel
- BIC: UBSWCHZH80A CHE-105.826.901 MWST CHF
- IBAN: CH09 0024 5245 7505 3401 F EUR
- IBAN: CH25 0024 5245 7505 3460 Z 1/1