Documents of external origin are considered to be regulations, laws, binding and/or applicable regulations, technical standards and any other public or [...]
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 [...]
The definition of which standards, laws and regulations to include in the list of external source documents depends on the regulatory [...]
Documents of external origin are checked by Notified Bodies during CE certification process, by Certification Bodies during ISO 13485:2016 certification process [...]
As of May 26, 2021, Switzerland has fully-fledged become a Third Country (Swiss Exit) and Swiss Manufacturers are treated as any [...]
Starting from May 26, 2021, in accordance with the full application of MDR (EU) 2017/745 Regulation on Medical Devices and in [...]
The designation of the Swiss Authorised Representative (CH REP) is required to market all Medical Devices, including legacy devices, i.e. devices [...]
Since Switzerland is considered a Third Country by the EU, its registration database is denied. Swiss REP and Importer in Switzerland [...]
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: [...]
The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which [...]