Clinical evaluation report for class I device

JP12345

Starting to get Involved
#11
Well, be careful there. First, the justification should (also) appear in the PMS plan, since PMCF is part of PMS. Then, PMCF is not limited to PMCF studies (popular misconception). There are a number of other possible activities in this area that require small effort and small money only. Check Annex XIV (5) and (6), especially (6.1):


If your justification for Art. 61 (10) is accepted, a similar justification should also work for all of PMCF. To be sure, I'd cover all 5 topics above and demonstrate why there is no PMCF necessary for each.
But if it is not accepted, be aware that PMCF can contain a number of tasks that you perform actively (as opposed to collecting complaints and the like). This could be as simple as specific questionnaires to a defined set of users, and of course research in competent authority databases and literature databases.
Thank you for this, the devices for which we justify use of Article 61 (10) are materials used during the process of creating a custom made device therefore clinical data is not available because the actual device (as sold) is not used directly on the patient, only the custom made device is used directly on the patient therefore I would assume that PMCF is also not possible due to this reason?
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#12
As I said, when the justification for Art. 61 (10) holds, it should also hold for PMCF, but you might want to change the focus and wording of the justification a bit.
 
Thread starter Similar threads Forum Replies Date
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 24
M SOPs, Plans and Report templates for Clinical Evaluation of EU MDR Other Medical Device Related Standards 11
TheMightyWife Copyright for articles used in CER (Clinical Evaluation Report) EU Medical Device Regulations 16
Q Evidence of precautions (clinical evaluation report, risk management report) EU Medical Device Regulations 6
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
Q Sample of the MEDDEV 2.7.1 rev 4 Clinical Evaluation Report wanted Document Control Systems, Procedures, Forms and Templates 18
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
E Biocompatability Clinical Evaluation Report ISO 13485:2016 - Medical Device Quality Management Systems 4
E Medical Device Class 2a CE Mark Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 3
E Clinical Evaluation Report for a Delivery System ISO 13485:2016 - Medical Device Quality Management Systems 2
K Clinical Evaluation Report Article Summary Requirements EU Medical Device Regulations 5
A Clinical Evaluation Report Examples and Finding Articles for support EU Medical Device Regulations 4
S Clinical Evaluation of equivalent device EU Medical Device Regulations 6
L Clinical evaluation plan EU Medical Device Regulations 13
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 10
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
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 10
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Clinical evaluation without clinical data - MDR Article 61(10) EU Medical Device Regulations 9
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 33
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 8
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 16
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational How to perform a clinical evaluation of medical devices – Part 2 – Level of clinical evidence and what sufficient clinical evidence means Medical Device and FDA Regulations and Standards News 9
M Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities Medical Device and FDA Regulations and Standards News 0
T EU MDR Article 61- Clinical Evaluation EU Medical Device Regulations 2
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
M Informational IMDRF – Proposed update to Clinical Evaluation documents Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
M Medical Device News CDRH Research Programs – VICTRE: Virtual Imaging Clinical Trials for Regulatory Evaluation Medical Device and FDA Regulations and Standards News 0
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
Rincewind Clinical Evaluation of very low risk medical devices EU Medical Device Regulations 3

Similar threads

Top Bottom