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Welcome, Trusha! I think you will find the regulatory field interesting and worthy of your focus. Best of luck. ------------------------------ Corey Jaseph RAC Senior Research Analyst politico Morongo Valley CA United States ------------------------------

I will note here that per the meeting agenda for the MDCG on December 11, 2023, five of the DSVG documents are in the endorsement process - the template and the ones on cardiac ablation, coronary stents, implanted electronic cardiac devices and breast implants. The CORE-MD project mentioned a planned ...

As far as I'm aware, all save EU27, Turkey, and Switzerland. ------------------------------ Corey Jaseph RAC Senior Research Analyst politico Morongo Valley CA United States ------------------------------

If the accessories are new add-ons to a product already on the market, they likely require a new submission to add them to the product. But you'd need to classify them, determine their intended use, etc. to confirm the need for a submission. If they change the intended use of the device they're used ...

We do know the MDCG is working on an update to the MIR form from the meeting agenda for the Post Market Surveillance Working Group https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=47862&fromExpertGroups=3565 From previous minutes, this will be version ...