应对紧迫 MDR 挑战的解决方案.pdf

1、Sponsored byMatthias Fink,M.D.,AKRA TeamSolutions to Your Pressing MDR ChallengesThis presentation is intended for educational purposes only and does not replace the legal text of the legislation,standards or guidance documents.The requirements on notified bodies will be used to share experience.Not

2、ified body names or detailsare not included.AKRA TEAM should not made liable for different opinions or interpretations of Competent Authorities,Notified Bodies,Conformity Assessment Bodies orany other relevant organizations.D|2Copyright AKRA TEAM.Do not distribute.Extension of the transitional perio

3、din Art.120(3)do not present any unacceptable risk to healthand safetyhave not undergone significant changes in design or intended purpose ANDfor which the manufacturers have already undertakenthe necessary steps to launch the certification process under the MDRAdaptation of QMS to MDRApplication fo

4、r conformity assessmentby a NB before a certain deadlineExtension of Transition Provisions per MDR Art.120Regulation 2023/60715 March 2023Applies only to devices thatImplementation of the MDR 2027 for class III and class IIb 2028 for class IIa and class I devicesExtension of the validity of certific

5、ates issued under MDD/AIMDD,if needed for legal or practical reasons(e.g.,third country markets access)Removal of the sell off provisionin MDR and IVDR|3Copyright AKRA TEAM.Do not distribute.Copyright AKRA TEAM.Do not distribute.6th Notified Bodies survey with data up to 31stOctober,4Biggest Challen

6、ges for Clinical Evidence49 Notified Bodies and 27 National Competent Authorities 100 MDCG Guidance Documents Learning Curve(NB and Manufacturer)Insufficient clinical data for legacy devicesExpectations on clinical evidence differ between NBs|Copyright AKRA TEAM.Do not distribute