Medical Device Registration Liechtenstein
Ministry of Health
Regulatory Authority
Medical Device Regulation
EU MDR 2017/745
Official Language
German
Classification
Class I, IIa, IIb, III and IV
Medical Device Registration in Liechtenstein
- Determine the classification of the device
- Implement QMS in accordance with ISO 13485
- Appoint Authorized Representative and Notified Body
- Medical devices must be CE marked.
- Prepare and submit the Technical File
- Register with competent authorities
- Once approved, manufacturer may market the medical device.
Documents Required
- Manufacturer business registration
- QMS ISO 13485 certificate
- CE certificate
- EC Declaration of Conformity (DoC)
- IFU in Bulgarian
- Risk Management File as per ISO 14971
- Clinical Evaluation
- Post-market surveillance
- Biocompatibility as per ISO 10993
- Product manufacturing flowchart
- Test reports
- Technical File
Post-market Requirements
Serious public health threats – 2 day
Death or serious health deterioration – 10 days
Other serious incidents – 15 days
Applicable QMS
ISO 13485
Registration Timeline
Class I – 6 weeks
Other depends on the type of the product.
Authorized Representative
Yes
License Validity
5 years