Medical Device News April 2024 Regulatory Update

Sponsor: Medboard: www.medboard.com/
EU
• MDR and IVDR national languages update - France accepts English
o MDR: bit.ly/3U3RxOo
• Which devices for Expert Panel - Active Implantable Device on Top: bit.ly/3VHdaFC
o 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products
o On Class III implantable - Top is with Active Implantable Devices
o 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: bit.ly/49gIy0Q
o SCHEER = Scientific Committee on Health, Environmental and Emerging Risks
• SCHEER on Phtalate - Update of the guidelines: bit.ly/4agdu2w
o Consultation until April 28th, 2024
• MDCG subgroup Agenda - What is coming?: bit.ly/3VKptkt
• MDCG 2024-3 on CIP - Clinical Investigation: bit.ly/3xp26D1
• New Notified Body RISE Sweden - Welcome to the team 3033: api.tech.ec.europa.eu/nando-p...
o 44 MDR NB
o 12 IVDR NB

UK
• MHRA: Electrical Devices in Clinical Trials - Advice on application with separate document: bit.ly/4czKzIi
Ireland
• HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: bit.ly/3J5pXu2
Turkey
• Reminder on MDR transition period - May 26th, 2024: bit.ly/3U5YOxy
o Turkey strongly inform the different parties regarding MDR transition
Events
• RAPS Euro Convergence - May 6-8 in Berlin-Germany: www.raps.org/europe-2024/home
• Medtech Conf Map: bit.ly/3TBkKis
• Packaging for Medical and Pharmaceutical - Design, Manufacturing and delivery: easymedicaldevice.com/packagi...
ROW
USA
• Ban devices - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: www.fda.gov/medical-devices/m...
o CNN article: edition.cnn.com/2024/03/25/he...
o Comments open until May 28, 2024: bit.ly/3xlP7Cd
o 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: www.fda.gov/media/177340/down...
o Minimum of 3 animals
o Animal Model: Canine and Porcine model instead of rodents
• FDA: Deviations on Neuralink lab - Animal Study good practices: reut.rs/3vChZp4
o Calibration of equipment's are not done
o Quality officials not signing documents
Australia
• Vigilance Reporting in Australia - For Recall and non-Recall: www.tga.gov.au/sites/default/...
o Recall action Template: bit.ly/3vJO1zq
Saudi Arabia
• Guidance on Surgical Sutures - This contains some cheat code: bit.ly/3J63ptg
o Endpoints that should be addressed
o Laboratories should be ISO/IEC 17025
o Shelf life should follow ASTM F1980
Brazil
• MOU between Brazil and Paraguay - Memorandum of Understanding: bit.ly/3J4MUNZ
o Bilateral cooperation on health surveillance
o Strenghtening regulatory capacity
•GMP validity from two to four years - If certified through MDSAP: bit.ly/3TJCvMH
•Prioritize registration of Dengue Diagnosis Devices - Submit Now: www.gov.br/anvisa/pt-br/assun...
o Combat dengue epidemic as a matter of urgency
India
• CDSCO: PSUR through online portal - From April 1st, 2024: bit.ly/3POSW9g
o Online portal: www.cdscomdonline.gov.in/NewM...
Malaysia
• Malaysia Faster approval - Establishment license application: bit.ly/440eS7n
o 14 to 21 Working days from date of application
o List of documents within the link
China
•China Guidelines on registration - Specific products: www.cmde.org.cn/xwdt/zxyw/202...
o Corneal Topograph
o Laparoscopic surgery system
o Optical Radiation Safety device
o Monkeypox virus nucleid acid detections agent: www.cmde.org.cn/xwdt/zxyw/202...
Podcast
o Episode 275 - FDA aligns QMSR with ISO 13485 (Naveen Agarwal): podcast.easymedicaldevice.com...
o Episode 276 - How to do Postmarketing Surveillance to right way? (Steve Curran): podcast.easymedicaldevice.com...
o Episode 277 - How to benefit from Survey to build Clinical Evidence? (Cesare Magri): podcast.easymedicaldevice.com...
• [e-mail]

[@tirthbrahmbhatt3866]

To file for NOB opinion upto how many months Validation data shall be required?

[@EasyMedicalDevice]

Not sure to understand the question. All depends on your product. This is generally discussed on clinical evaluation

[@EasyMedicalDevice]

Not sure to understand your question. This is usually discussed during clinical evaluation

[@tirthbrahmbhatt3866]

@@EasyMedicalDevice for Drug Device Combination Products?