Clinical Evaluation MEDDEV Guidelines SmackDown - 2017

Sam Lazzara

Trusted Information Resource
#1
I have prepared a side-by-side comparison between MEDDEV 2.7/1 Rev. 4 (2016) and MEDDEV 2.7.1 Rev. 3 (2009) guidelines. An MS Word version is attached. Nothing magical about what I did - very boring though....

This could be an important first step to help folks update their Clinical Evaluation SOP (or write one for the first time) and/or update their "old" clinical evaluation reports.

Please let me know if there are improvements that can be made.

Sam
 

Attachments

Elsmar Forum Sponsor

Edward Reesor

Trusted Information Resource
#2
Thanks Sam!
I made a similar document for our new technical file template and added the contents of the right hand column as a comparator for when I perform the review of our technical files. I find that as I go through each review, having reference to the previous version is very helpful.
 
#3
Most appreciated. Minor typo on every page: MEDDEV 2.7/1 Rev 4 (2009) versus MEDDEV 2.7.1 Rev 3 (2016) should be MEDDEV 2.7/1 Rev 4 (2016) versus MEDDEV 2.7.1 Rev 3 (2009)
 
Thread starter Similar threads Forum Replies Date
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 0
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
M Clinical Evaluation - MEDDEV 2.7/1 rev4 - Literature route Other Medical Device Related Standards 2
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 15
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
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
bio_subbu Clinical Evaluation - MEDDEV 2.7.1 Rev. 3 Released - December 2009 EU Medical Device Regulations 0
S Clinical Evidence and Expert Evaluation - Guidance Notes (MEDDEV 2.7.1) ISO 13485:2016 - Medical Device Quality Management Systems 18
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 6
M Clinical Evaluation Plan vs. PMCF Plan EU Medical Device Regulations 19
M Can someone share a scrubbed version of Clinical Evaluation Plan (CEP) EU Medical Device Regulations 1
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 12
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 0
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
D Clinical Evaluation Report - Consultant Recommendations Consultants and Consulting 9
M CER (Clinical Evaluation Reports) updates - Product Codes EU Medical Device Regulations 2
A Medical device CER (clinical evaluation report) training/seminar services 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
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
H Addressing of Undesirable side-effects, harms, risks and side-effects in clinical evaluation report (CER) EU Medical Device Regulations 12
W Literature used in the clinical evaluation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Medical device CER (clinical evaluation report) according to MDR EU Medical Device Regulations 10
M SOPs, Plans and Report templates for Clinical Evaluation of EU MDR Other Medical Device Related Standards 7
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
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
Rincewind Clinical Evaluation of very low risk medical devices EU Medical Device Regulations 3
SK13485 Can a literature alone be used for the purpose of Clinical Evaluation of a device? EU Medical Device Regulations 6
R Scope and plan of the clinical Evaluation CE Marking (Conformité Européene) / CB Scheme 3
M MDR Clinical Evaluation & investigation (SUMMARY of changes) EU Medical Device Regulations 2
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
Gamula CFDA Clinical Evaluation Report (China) China Medical Device Regulations 4
shimonv CFDA Technical Guidelines for Clinical Evaluation on Medical Devices (English) China Medical Device Regulations 8
E Clinical Evaluation of IVD Medical Devices CE Marking (Conformité Européene) / CB Scheme 8
S Clinical evaluation standard operating procedure / SOP for medical devices Document Control Systems, Procedures, Forms and Templates 1
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 11
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
M Clinical Evidence - Clinical Evaluation Report for Class I medical devices EU Medical Device Regulations 1
P What to include in a Clinical Evaluation Plan EU Medical Device Regulations 2
R FDA's guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies Other US Medical Device Regulations 3
M Clinical Evaluation sample for X-Ray Machine CE Marking (Conformité Européene) / CB Scheme 1
Similar threads


















































Top Bottom