Medical device CER (clinical evaluation report) according to MDR

S

sebastien

#1
hello,
I'm looking for clinical evaluation report (CER) template according to the new medical device regulation (MDR) not Meddev 2.7 rev 4.
I'm also looking for templates for clinical evaluation plan , PMCF (post marketing clinical follow up)

could anyone help me?

thank you
sebastien
 
Elsmar Forum Sponsor

Rincewind

Involved In Discussions
#3
Looking at the MEDDEV and the MDR it seems, at least to me, they correspond very well and from my experience usually the notified body requests the CER structured according the MEDDEV 2.7/1 rev. 4.
So what exactly do you think is not covered by the MEDDEV?
 

Sullen-gent

Involved In Discussions
#4
hello,

On this point I had assumed the same, that MDR and MEDDEV rev. 4 are aligned, and I have even been to meetings where that was said by the subject matter experts. However, I just reached out to Bsi to try and arrange some CER MEDDEV rev. 4 training (as I'm new to my current role). They have suspended this training as they say they need to make it MDR compliant and won't release it until Q3 of 2019. This was a salesperson I was speaking to so there is certainty room for confusion but taken at face value it looks the MDR does impact on MEDDEV rev. 4 interpretation in some way.

On this note is anyone aware of UK based CER training courses that are any good?
 

Thulasidharan

Starting to get Involved
#5
Hello All,
MEDDEV 2.7.1, Rev: 4 is based upon MDD only.
"A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC"
According to MDR related to CER still now only requirements available. No guidance will be updated by MEDDEV.
 
J

John2019

#6
I need a CER report writer interested ones please ping me privately with sample of your previous works
 

Ronen E

Problem Solver
Staff member
Moderator
#7
hello,

On this point I had assumed the same, that MDR and MEDDEV rev. 4 are aligned, and I have even been to meetings where that was said by the subject matter experts. However, I just reached out to Bsi to try and arrange some CER MEDDEV rev. 4 training (as I'm new to my current role). They have suspended this training as they say they need to make it MDR compliant and won't release it until Q3 of 2019. This was a salesperson I was speaking to so there is certainty room for confusion but taken at face value it looks the MDR does impact on MEDDEV rev. 4 interpretation in some way.

On this note is anyone aware of UK based CER training courses that are any good?
As far as I heard rev. 4 is under review/update and rev. 5 will issue at some point and be aligned with the MDR.

Here is something else also under construction: Proposed update to Clinical Evaluation documents
 

Sullen-gent

Involved In Discussions
#9
As far as I heard rev. 4 is under review/update and rev. 5 will issue at some point and be aligned with the MDR.
Hello, thanks for that link will try to have a go reading it. I went on a MDTi course on MDR and CER and there are some points raised in the regulation that are not completely covered by the MEDDEV e.g. clinical benefit.

But one of the course attendees was a member of the EU commission working groups and told us all that the MEDDEV update has effectively been 'parked' and that it wouldn't be available for some time.
 

Marcelo

Inactive Registered Visitor
#10
Clinical benefits are covered by the current MEDDEV, but are defined under clinical performance.

Clinical performance: behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s). [EN ISO 14155:2011]
The "response of the subject" is the clinical benefit.

Why the MDR did was just separe the topics in different definitions, and put a lot more emphasis on benefits.
 
Thread starter Similar threads Forum Replies Date
P Adding "new" medical device to existing CER - under MDD CE Marking (Conformité Européene) / CB Scheme 1
A Medical device CER (clinical evaluation report) training/seminar services EU Medical Device Regulations 2
H CER - Considering similar device/other medical devices for as relevant literature CE Marking (Conformité Européene) / CB Scheme 4
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 0
A Labeling Requirements for Medical Device Travel Case US Medical Device Regulations 3
Judy Abbott Guideline as for devices utilizing plants and their derivatives in medical device US Food and Drug Administration (FDA) 6
B Registration of a CE-marked medical device in Japan -Will they accept conformity with GSPRs? Japan Medical Device Regulations 0
B Software as a Medical Device - Language Requirements EU Medical Device Regulations 6
C Medical Device registration CE Marking (Conformité Européene) / CB Scheme 3
B Software as a NON-medical device Medical Information Technology, Medical Software and Health Informatics 21
M Can you import medical device not FDA approved into the USA under an IND application? US Food and Drug Administration (FDA) 2
A Algorithm As a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 3
A Medical Device Software POC Medical Device and FDA Regulations and Standards News 6
T Medical Device Registration in Saudi Arabia Other Medical Device Regulations World-Wide 1
Y Brazilian lab requirement for medical device manufacture Other Medical Device Regulations World-Wide 1
W Medical Device - fixture qualification and MSA Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
H Medical Device Labelling ISO 13485:2016 - Medical Device Quality Management Systems 11
D One Software as Medical Device product or two? EU Medical Device Regulations 4
R How to find the proper the fieids of IVD distributers and develop the medical device markets in Thailand? Manufacturing and Related Processes 0
K Regulatory Aspect of Embedding 4G/5G communication technologies into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
B Documenting Medical Device Complaints after End of Life? Medical Device and FDA Regulations and Standards News 0
M Medical Device License as Distributor Canada Medical Device Regulations 9
M Preparing a document for Raw Material of Medical Device EU Medical Device Regulations 1
R Medical device regulations in African countries Other Medical Device Regulations World-Wide 0
Z Swiss Authorized representative & non-medical device regulations Other Medical Device Regulations World-Wide 0
T FDA UDI Question - Class II Medical Device Other US Medical Device Regulations 2
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
P Brexit Germany - Import Medical Device For Clinical Study EU Medical Device Regulations 0
M Medical Device Marketing Material - Control of Social Media 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ed Panek Make sure you hire competent QA RA Folks before making a "Medical Device." Coffee Break and Water Cooler Discussions 1
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
B Reprocessing of an accessory for a medical device EU Medical Device Regulations 4
A Class 1 medical device - Thailand Other Medical Device Regulations World-Wide 0
P Interchangeable/alternative parts in BOM (medical device) Manufacturing and Related Processes 4
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
J Shoe Covers - medical device class I EU Medical Device Regulations 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 4
C CE Marking - Medical Device Accessories EU Medical Device Regulations 0
H Existing cloud based medical device - questions regarding improving the processes IEC 62304 - Medical Device Software Life Cycle Processes 6
K Unused Service Parts in Newly Manufactured Medical Device? Other US Medical Device Regulations 1
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
J Medical device repairs (to upholstery) Manufacturing and Related Processes 4
Ed Panek Apple Provides New Medical Device Cautions 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Does a medical device active (zinc oxide) needs BPR registration in EU? Other ISO and International Standards and European Regulations 5

Similar threads

Top Bottom