Medical Device News April 2024 Regulatory Update Medical Device made Easy Podcast

Sponsor:



Medboard: https://www.medboard.com/



EU



MDR and IVDR national languages update - France accepts English



MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf



IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf



 

Which devices for Expert Panel - Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf

94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products



On Class III implantable - Top is with Active Implantable Devices



Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed):



Vascular and cardiac prostheses



Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis



Implantable prosthetic and osteosynthesis devices



 



 

Annex XVI: Is Brain Stimulation device risk? -  SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf

SCHEER = Scientific Committee on Health, Environmental and Emerging Risks



 



SCHEER on Phtalate - Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en



Consultation until April 28th, 2024



 



MDCG subgroup Agenda - What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf



MDCG 2024-3 on CIP - Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf



New Notified Body RISE Sweden - Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true



44 MDR NB



12 IVDR NB



 



UK



MHRA: Electrical Devices in Clinical Trials - Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf



Ireland



HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf



Turkey



Reminder on MDR transition period - May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf



Turkey strongly inform the different parties regarding MDR transition



 



Events



RAPS Euro Convergence - May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home



Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/



Services



Packaging for Medical and Pharmaceutical - Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/



ROW



USA



Ban devices - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans



CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html



Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior



Bans



Prosthetic Hair Fibers since 1983



Powdered Surgeon's Gloves since 2017



Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024



 



 



Animal Studie for Dental Bone Grafting devices - Choose the right animal Model: https