UKCA marking for medical devices
We explain how to obtain the UKCA Mark for medical devices after the entry into force of the MHRA regulation....
24 January, 2022
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EpisKey Medical Consulting is a new partner of Ticbiomed!
We became a member of Ticbiomed, an association that promotes collaborative projects in digital health....
23 November, 2021
Postponement of the entry into force of the IVDR Regulation
On 14 October, the European Commission proposed a postponement of the entry into force of the IVDR Regulation, which was due to enter into force on 26 May 2022....
14 October, 2021
Clinical investigations with medical devices
In order to understand how clinical investigations with medical devices should be conducted, the European Union provides a set of guidelines in the MDR 2017/745 and IVDR 2017/746 regulations for in vitro diagnostic medical devices. ...
01 September, 2021
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