Updates on the Ongoing guidance development within MDCG Subgroups

por Asphalion

4 years ago
MDR, MDCG, guidance, artificial intelligence, antibody tests, medical devices

Now that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...

MDR | Guidance documents and updates on clinical investigation and evaluation

por Asphalion

4 years ago
guidance, MDR, medical devices

Although the date of application of the Medical Devices Regulation (MDR) has been postponed, on 26 May 2021 the Regulation will become fully applicable, following the transition period. As previous...

Updated version of the document 'EMA post-authorisation procedural advice for users of the centralised procedure'

por Asphalion

4 years ago
EMA, guidance, authorisation

Last week, European Medicines Agency (EMA) updated the guidance document “European Medicines Agency post-authorisation procedural advice for users of the centralised procedure”.

Telstar situation related to the Coronavirus Outbreak

por Telstar

4 years ago
Coronavirus Outbreak, protection, health, guidance

To tackle the situation related to the Coronavirus outbreak, Telstar is operating under a business continuity plan which is taking into consideration three goals: