Re: [PSES] Active Implantable Medical Devices

This one: ETSI DRAFT FOR APPROVAL - EN 301 489-35 ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands; Harmonised Standard covering the essen

[PSES] Active Implantable Medical Devices

Dear Members, For active implantable medical devices to comply with the RED requirements: 1. Do all active implantable medical devices require Notified Body’s involvement per RED? From online search ( https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en), it seems the a