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Friday 5 February 2021
By Mitch on Friday 5 February 2021, 12:40 - Regulations
A Notice was published in the Federal Register the 15th January 2021, about the exemption of a long list of medical devices from premarket notification. This list, found in table 6 of the Notice, contains 83 class II devices.
Yet, we have to wait for 120 days, to see this Notice published with the list in its final version.
Wednesday 9 October 2019
By Mitch on Wednesday 9 October 2019, 14:39 - Regulations
We know that Drug Prescription Assistance Software are software as a medical device, thanks to the European Court of Justice. But how to CE mark that kind of software?
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).
Friday 19 January 2018
By Mitch on Friday 19 January 2018, 14:15 - Regulations
Here is a quick follow-up of the new version of the FDA Guidance titled Medical Device Accessories – Describing Accessories and Classification Pathways, published in December 2017. This comes a bit in parallel to the Section 3060 guidance described in the previous post on the 21st Century Cures Act.
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