Have you seen the MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements?
Tuesday 14 June 2022
MDCG 2022-11 - Monty Python and the Holy Grail
By Mitch on Tuesday 14 June 2022, 21:41 - Misc
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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.