New EU MDR CMRs and Allergens

To maintain EU market access by 2028, device registrations must account for forty (40) new Carcinogens, Mutagens, and/or Reproductive Toxicants (CMRs) and ten (10) new allergens. 0:00 - 2:56 - Overview - Agenda 2:57 - 3:51 - Claigan EU MDR 3:52 - 5:14 - EU MDR and CMRs 5:15 - 5:47 - EU MDR Justification Document Full Webinar 5:48 - 7:18 - EU MDR an Allergens 7:19 - 8:06 - What are CMRs 8:07 - 8:47 - ATP Updates to CMR 8:48 - 9:43 - ATP Updates to CMR ATP 24 9:44 - 11:48 - EU MDR Allergens 11:49 - 12:16 - EU MDR Allergens Well Recognized Allergens 12:17 - 14:08 - Allergens Additions 14:09 - 18:01 - Allergens and Medical Devices 18:02 - 22:46 - Complete Failure of Standard EU MDR Tests 22:47 - 25:51 - Reminder on Standard EU MDR Tests 25:52 - 26:16 - Allergen Test Issues 26:17 - 31:06 - Biological Evaluation Plan (BEP) Allergens 31:07 - 32:08 - EU MDR Allergens Acrylates 32:09 - 33:07 - ATP Updates to CMR 33:08 - 34:10 - ATP 23 - High Risk Substance Tetrahydrofurfuryl methacrylate 34:11 - 35:10 - ATP 23 - High Risk Substance Trimethyl Phosphate 35:11 - 35:52 - ATP Updates to CMR ATP 24 35:53 - 37:31 - ATP 24 - High Risk Substance(s) Borates 37:32 - 38:09 - ATP 24 - High Risk Substance(s) Bromides 38:10 - 39:13 - ATP 24 - High Risk Substance(s) Bisphenol F 39:14 - 40:42 - ATP 24 - High Risk Substance(s) 4-phenylbenzophenone (PBZ) 40:43 - 42:37 - ATP 24 - High Risk Substance(s) N-I,3-dimethylbutyl-N'-phenyl-p-phenylenediamine 42:38 - 43:52 - Allergens Additions 43:53 - 45:45 - Updated 45:46 - 46:53 - Biological Evaluation Plan (BEP) Allergens 46:54 - 47:29 - Claigan EU MDR 47:30 - 48:31 - Claigan Updating Previously Tested Products 48:32 - 49:40 - Biological Evaluation Plan (BEP) Allergens 49:41 - 52:39 - Q&A