EU Clinical Trial Startup vs. US IDE (Investigational Device Exemption)

D

dblnkl

#1
When considering your Class III medical device development time line: R&D + V&V (with design controls) are required prior to a US IDE trial. When can an EU CE mark trial begin? Can it begin with some animal testing under the R&D phase or does it have to await completion of V&V, or somewhere in between?
 
Elsmar Forum Sponsor

Sam Lazzara

Trusted Information Resource
#2
You will need European country Competent Authority (CA) approval before you initiate a clinical investigation in the country under their authority. In my experience, the expectation is that the non-clinical MDD/AIMDD Essential Requirements need to be met before you start the study. From my perspective, this means you will need to have successfully completed design verification including non-human safety testing. Proof of this typically needs to be submitted to the CA.

The clinical study is basically a design validation study, so I don't think you would be expected to have completed design validation before you initiate the study.

Regarding process validation, other than having completed sterilization validation (or batch-release validation) and perhaps sterile barrier heat seal validation, I do not think there is an expectation that "process" validations would be completed before a pre-market clinical study is initiated.

ASIDE: For USA clinical investigations under an IDE per 21 CFR 812, you are specifically exempted from compliance with all parts of 21 CFR 820 except for 820.30 (design controls). I would apply the same general philosophy as described above.
 
Thread starter Similar threads Forum Replies Date
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
R Clinical Trial to sell in the EU - Necessary or Not? ISO 13485:2016 - Medical Device Quality Management Systems 5
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
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
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
P IDEs and Clinical Investigators - Advice About Records? Other US Medical Device Regulations 3
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 11
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
D Classification of product for clinical trials EU Medical Device Regulations 14
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 11
T Clinical evaluation of a new medical device EU Medical Device Regulations 0

Similar threads

Top Bottom