MEDDEV 2.7/1 Rev 4 Appendix - A11 - Declarations of Interests

K

kreid

Involved In Discussions
Has anyone had discussions with their notified body on the appendix - 'A11. Information on declarations of interests' and how they will oversee this aspect?

From the text it seems to imply, to me, that Evaluators should be independent of the company carrying out the CER and of the device.

I would have thought most of the evaluators of a CER will be employees of the legal manufacturer which will make fulfilling this part a creative exercise.

Also do you think the MEDDEV includes the Author of the CER as an evaluator?

Thanks, in advance.
 
P

Pads38

Moderator
From my reading of A11 I would suggest that it does not rule out company employees being involved in the writing of the CER.

Rather, it requires transparency - clear identification of who gets what.

This sort of deceleration is standard for publishing in the academic press. And it is largely aimed at any academics / clinicians involved. - Does the surgeon involved in the review of your new hip implant get a royalty on sales? or a discount?
 
K

kreid

Involved In Discussions
Yes, I agree it makes complete sense when a company is using external clinicians to validate work.

It is just that it seems so focussed on this type of relationship and seems to ignore any other possibility and that there will also be internal people evaluating the data.

I hope it is applied with common sense.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 3
FoGia MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
E Can we still use MEDDEV 2.4/1 rev. 9 when classifying a medical device product under MDR? EU Medical Device Regulations 4
L I'm looking for Translation Procedure Guide MEDDEV 2.5/5 Rev.2 (NOT Rev.3) CE Marking (Conformité Européene) / CB Scheme 0
dgrainger Informational Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 EU Medical Device Regulations 1
M CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable? EU Medical Device Regulations 7
K MEDDEV 2.4/1 rev. 9 Classification EU Medical Device Regulations 1
TheMightyWife Clinical Evaluation MEDDEV 2.7.1 Rev 4 demonstration of equivalence EU Medical Device Regulations 6
J CER - Literature search strategy and PMV data Timeline - MEDDEV 2.7.1/ Rev 4 CE Marking (Conformité Européene) / CB Scheme 2
S Gap Analysis MDR req/MEDDEV 2.7.1 rev 4 EU Medical Device Regulations 3
H CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4 CE Marking (Conformité Européene) / CB Scheme 9
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
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
R Clinical Evaluation according to MEDDEV 2.7.1 (Rev 4) - seeking template ISO 13485:2016 - Medical Device Quality Management Systems 6
FoGia MEDDEV 2.7/1 rev 4 - Clinical Performance & Clinical Safety Claims EU Medical Device Regulations 3
E Gap Analysis between MEDDEV 2.7/1 rev.4 vs. rev.3 wanted EU Medical Device Regulations 3
M MEDDEV 2.7/1 rev.4 published - June 2016 EU Medical Device Regulations 42
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
M MEDDEV 2.12.1 rev 6 Trending of Non-Reportable Events question ISO 13485:2016 - Medical Device Quality Management Systems 8
bio_subbu European Medical Devices Classification ?MEDDEV 2. 4/1 Rev. 9 June 2010? ISO 13485:2016 - Medical Device Quality Management Systems 5
T Vigilance System MEDDEV 2009 changes - MEDDEV 2.12-1 rev 6 for Vigilance System EU Medical Device Regulations 1
bio_subbu Clinical Evaluation - MEDDEV 2.7.1 Rev. 3 Released - December 2009 EU Medical Device Regulations 0
A Contradictions in the reporting timelines of IVD Directive and MEDDEV 2.12-1 Rev 5 ISO 13485:2016 - Medical Device Quality Management Systems 2
J EU Vigilance (updated MEDDEV rev.5) - Internal Forms EU Medical Device Regulations 13
Z MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure EU Medical Device Regulations 18
G MEDDEV 2.12-1 rev. 5 released ISO 13485:2016 - Medical Device Quality Management Systems 0
T The “use-by“ time limit - Terminology discrepancy - MEDDEV & HS EU Medical Device Regulations 0
K Measuring Function MEDDEV 2.1/5 relation with MDD 93/42/EEC CE Marking (Conformité Européene) / CB Scheme 2
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
pashah Looking for Clinical Evaluation SOP acc. MEDDEV and EU MDR Other Medical Device Related Standards 1
J MEDDEV 2.12/1's new MIR & IMDRF terms & codes (IMDRF Annex) EU Medical Device Regulations 1
Ronen E Informational The future of MEDDEV 2.7/1 EU Medical Device Regulations 4
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
T MEDDEV 2.7/1 r4 vs. IMDRF/SaMD WG/N41 Other Medical Device Related Standards 3
P Label Translations - Translation procedure to meet the requirements of MEDDEV 2.5/5 ISO 13485:2016 - Medical Device Quality Management Systems 4
Sam Lazzara Clinical Evaluation MEDDEV Guidelines SmackDown - 2017 EU Medical Device Regulations 3
E CER (Clinical Evaluation Report) MEDDEV Version 4 Template wanted CE Marking (Conformité Européene) / CB Scheme 5
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
J Where to get meddev FSCA (Field Safety Corrective Actions) trainings EU Medical Device Regulations 7
Y Transition Period for MEDDEV 2.7.1 EU Medical Device Regulations 8
C MEDDEV equivalent requirement to CFR 806.20 EU Medical Device Regulations 2
J Good training or seminars to attend for MEDDEV 2.12-1 recommendations wanted EU Medical Device Regulations 3
S NB-MED, NBOG, IMDRF and MEDDEV hierarchy EU Medical Device Regulations 3
M Australian Meddev Regulations Updated 5 Nov 2014 Other Medical Device Regulations World-Wide 0
B Inquiry about MEDDEV 2.12/2 rev2 - PMCF studies EU Medical Device Regulations 3
D Vigilance Trend reporting requirements of Meddev 2.12/ver 7 in the EU Document Control Systems, Procedures, Forms and Templates 1
N MEDDEV guideline on Post Market Surveillance (PMS) EU Medical Device Regulations 8
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8

Similar threads

Top Bottom