Is clinical trial necessary?

#1
Hello
I am a beginner in MDR topic and I have a question to you, as you are a brilliant source of knowledge :)
Our company manufacture novel (no equivalent device on the market), substance-based, class IIa (rule 21) medical device used on skin to alleviate symptoms of some skin disease. Is there (by any chance) an option to acquire MDR certificate without conducting a clinical trial?
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#3
Definition of clinical data (which is required for certification)., Article 2 (48):
‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
  • clinical investigation(s) of the device concerned,
  • clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
  • reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
  • clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
From your description, it seems you have data from none of the four sources mentioned. The only one you can create yourself is the first one ...
 
Thread starter Similar threads Forum Replies Date
R Clinical Trial to sell in the EU - Necessary or Not? ISO 13485:2016 - Medical Device Quality Management Systems 5
S Clinical trial requirements for UKCA mark in UK UK Medical Device Regulations 4
I France clinical trial requirements EU Medical Device Regulations 1
D Clinical Trial for Medical devices in Canada Canada Medical Device Regulations 2
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
L Clinical Trial and Finished Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4
U Do we need clinical trial data for Class IIa medical device under MDR EU Medical Device Regulations 7
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
T Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial Other US Medical Device Regulations 9
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
T Medical device Clinical trial exemption list China Medical Device Regulations 2
F China Device Assisted Technology Clinical Trial China Medical Device Regulations 4
J Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
H IVD in US Phase III Clinical Trial - Non-CE Marked and Non-FDA Approved Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M Does Medical Device Usability Study = Clinical Trial? Other Medical Device and Orthopedic Related Topics 26
Q South Africa Clinical Trial Inspections by MCC Quality Manager and Management Related Issues 1
S Clinical Trial Informed Consent Forms ("retro-signing") US Food and Drug Administration (FDA) 2
A Singapore - Requirements for Import of Medical Devices for Clinical Trial Other Medical Device Regulations World-Wide 2
B Health Canada Acceptance Policy of Foreign Clinical Trial Data for Devices Canada Medical Device Regulations 2
C Retention of Clinical Trial Data after a Clinical Trial has ended Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
N Can a Clinical Trial Lead Investigator Surgeon be a Expert Clinical Evaluator? ISO 13485:2016 - Medical Device Quality Management Systems 3
R CE Mark requirements on US Clinical Trial Product CE Marking (Conformité Européene) / CB Scheme 2
I IVD product for use in a Drug Clinical Trial (FDA matters) US Food and Drug Administration (FDA) 3
J Labeling Contraindication vs. Clinical Trial Exclusion Criterion Other US Medical Device Regulations 7
bio_subbu CDSCO issues Draft Guidelines for Approval of Clinical Trial & New Drugs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D EU Clinical Trial Startup vs. US IDE (Investigational Device Exemption) ISO 13485:2016 - Medical Device Quality Management Systems 1
I Medical Device Clinical Trial Audit Checklist wanted ISO 13485:2016 - Medical Device Quality Management Systems 2
S Clinical Trial Study Reports - SOP Other US Medical Device Regulations 3
S Roadmap for Clinical Trial for Orthopaedic Medical Devices EU Medical Device Regulations 2
P Medical Device Clinical Trial Labels Other Medical Device and Orthopedic Related Topics 3
N Requirement of GCP for a clinical trial of IVD EU Medical Device Regulations 5
K Does a Radiotherapy device need a clinical trial for getting registered in China? ISO 13485:2016 - Medical Device Quality Management Systems 2
E DESIGN VALIDATION, USABILITY AND CLINICAL EVALUATION request Medical Device and FDA Regulations and Standards News 0
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
Watchcat REGULATORY WATCHCAT - De Novo Proposed Rule - Clinical Investigations Other US Medical Device Regulations 0
S Clinical Evaluation of equivalent device EU Medical Device Regulations 6
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
S Summary of safety and clinical performance and Article 120(3) of the MDR EU Medical Device Regulations 4
J EU equivalent to Clinical Decision Support Software EU Medical Device Regulations 3
L Clinical evaluation plan EU Medical Device Regulations 13
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 11
A Clinical Investigation - US/EU Medical Device and FDA Regulations and Standards News 5
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
A Qualification of clinical assessment scales EU Medical Device Regulations 1

Similar threads

Top Bottom