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EU MDR 2017/745
Manufacturers of medical devices looking to sell their products in the European Union (EU) will need to understand and comply with the regulatory requirements of
What is a PRRC? PRRC is the abbreviated form of “Person Responsible for Regulatory Compliance” and is one of the requirements for compliance with the
Background In the European Union, the legal manufacturer is understood to be the entity which has the final responsibility for the device being placed on
The EU Medical Device Regulation 2017/745 regulates custom-made medical devices (CMD) differently to other medical devices.
One of the key new concepts introduced by the EU Medical Device Regulation 2017/745 is the regulation of “Products without a medical intended purpose” which