Medical Device News April 2024 Regulatory Update

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://www.fda.gov/media/177340/download

Minimum of 3 animals

Animal Model: Canine and Porcine model instead of rodents

FDA: Deviations on Neuralink lab - Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/

Calibration of equipment's are not done

Quality officials not signing documents

Australia

Vigilance Reporting in Australia - For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf

Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates

Saudi Arabia

Guidance on Surgical Sutures - This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf

Endpoints that should be addressed

Laboratories should be ISO/IEC 17025

Shelf life should follow ASTM F1980

Brazil

MOU between Brazil and Paraguay - Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento

Bilateral cooperation on health surveillance

Strenghtening regulatory capacity

GMP validity from two to four years - If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao

Prioritize registration of Dengue Diagnosis Devices - Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue

Combat dengue epidemic as a matter of urgency

India

CDSCO: PSUR through online portal - From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI=

Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage

Malaysia

Malaysia Faster approval - Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days

14 to 21 Working days from date of application

List of documents within the link

China

China Guidelines on registration - Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html

Corneal Topograph

Laparoscopic surgery system

Optical Radiation Safety device

Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html

Podcast

Podcast Nostalgia

Episode 275 - FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/Episode 276 - How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/

Episode 277 - How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/

Easy Medical Device

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