SBS - the best value in QMS software

EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean?

ShRam

Starting to get Involved
#1
Hi,

In EU MDR, Annex XIV-Clinical Evaluation Plan says, "a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects"

What do these methods mean?

TIA!
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
methods is the procedure.... plan, sample size, inclusion, exclusion, protocol, instrumentation, monitoring, etc.
 

Biomedical_engeener

Starting to get Involved
#3
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.
 

ShRam

Starting to get Involved
#5
Is clinical evaluation needed if device is already place on the market under MDD ?
What is the dofference between Clinical evaluation and PMCF ?
Our device is a custom made device, so we was self-certificated before.

Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation. Clinical investigations that are done after your product is placed in the market is Post Market Clinical Follow up (PMCF).
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation.
Should be: Performing clinical studies before placing your product in a market to evaluate the risk/benefits or side effects is clinical evaluation investigation.
 

Philip B

Involved In Discussions
#10
Recommend you read the MEDDEV guidance on clinical evaluation (2.7/1 rev 4), we based ours on this. It's a lengthy and detailed document so you need to put aside considerable time for this. If you meet the MEDDEV there is a presumption you meet the regulation.
 
Thread starter Similar threads Forum Replies Date
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 0
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
T EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) EU Medical Device Regulations 0
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 5
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
W MDR Annex I chapter 23.2 (q) - Information required on the label EU Medical Device Regulations 17
R MDR & depth of review by NB's EU Medical Device Regulations 7
U EU-MDR: complicated supply chain EU Medical Device Regulations 0
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 14
G MDR translation requirements EU Medical Device Regulations 3

Similar threads

Top Bottom