What is meant by documents (or list) of external origin?
Documents of external origin are considered to be regulations, laws, binding and/or applicable regulations, technical standards and any other public or [...]
20 09 2023
20 09 2023
20 09 2023
20 09 2023
Why is it necessary to implement and manage the process of compliance with standards, laws and regulations?
The implementation and management of the compliance process with standards, laws and regulations is necessary to market Medical Devices and IVDs [...]
20 09 2023
20 09 2023
What does the list of documents of external origin depend on?
The definition of which standards, laws and regulations to include in the list of external source documents depends on the regulatory [...]
20 09 2023
20 09 2023
Who controls the updating of documents of external origin?
Documents of external origin are checked by Notified Bodies during CE certification process, by Certification Bodies during ISO 13485:2016 certification process [...]
14 12 2021
14 12 2021
Swiss Exit: what requirements should EU Manufacturers of Medical Devices satisfy now?
As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as any [...]
14 12 2021
14 12 2021
Why is Switzerland considered a Third Country by Europe?
Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in [...]
14 12 2021
14 12 2021
For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices [...]
14 12 2021
14 12 2021
Do Swiss Authorised Representative and Importers of Medical Devices have to register in EUDAMED?
Since Switzerland is considered a Third Country by the EU, its registration database is denied. Swiss REP and Importer in Switzerland [...]
20 08 2020
20 08 2020
Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?
The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following: [...]
20 08 2020
20 08 2020
What is the “sell off” provision?
The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which [...]
