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Friday, 27 June 2025
By Mitch on Friday, 27 June 2025, 13:00 - Regulations
MDCG 2019-11 rev.1 was published in June 2025. Almost 6 years after the first version.
Despite the passage of time, and the advent of modern AI, nothing has really changed. The rigorous approach is more than ever present in this guide.
Friday, 26 July 2024
By Mitch on Friday, 26 July 2024, 13:12 - Regulations
And this is the Australian TGA who demonstrates that.
Tuesday, 14 June 2022
By Mitch on Tuesday, 14 June 2022, 21:41 - Misc
Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?
Friday, 13 May 2022
By Mitch on Friday, 13 May 2022, 13:55 - Regulations
Post-Market Surveillance (PMS) is one of the strengthened requirements of the Medical Device Regulation (MDR). Performing an effective PMS can be a time consuming task, shared by several departments of MD manufacturers. This is also true for SaMD.
Thursday, 31 October 2019
By Mitch on Thursday, 31 October 2019, 14:03 - Regulations
Here we are! White smoke over the European Parliament! The MDCG 2019-11 guidance on qualification and classification of medical device software (MDSW) was published the 11th of October 2019.
Sunday, 26 May 2019
By Mitch on Sunday, 26 May 2019, 14:00 - Regulations
Today is the 26th of May 2019. Rings a bell? In one year exactly, your class I MD software will be living in borrowed time on the EU market.
Why?
Because of rule 11 of 2017/745/UE Medical Device Regulation (MDR).
Saturday, 6 May 2017
By Mitch on Saturday, 6 May 2017, 10:59 - Regulations
Hello,
The Medical Device Regulation and In-Vitro Device Regulation have been published the 5th May 2017!
See the Official Journal of the EU.
