Requirement for independent certification of device using an ISO 17025 laboratory

rob73

rob73

looking for answers
Hi Guys
What do we think about the requirement for device to have independent certification using an ISO 17025 laboratory. A friend has been asked for this in a new NHS contract, setting aside that if this is a new contractual agreement he may not have any choice, is this strictly necessary for CE marking a class 11a device? BTW he's being asked for certification to [FONT=&quot]BS EN ISO 8836:2014 suction catheter by an ISO 17025 test house.
****edit*****
Since found out that BS EN ISO 8836:2014 does not appear in the official journal, so it is not harmonised, but could still be considered stat of the art??



[/FONT]
 
Last edited:
Ronen E

Ronen E

Problem Solver
Moderator
I don’t know about the NHS, they may require whatever they like (and seem to be doing so).
Regarding CE marking, I assume the reference is the MDD, not MDR - correct?
If so, it’s not an MDD requirement for CE marking a class IIa catheter, unless the manufacturer chooses to go the annex III/IV route. Did they?
 
rob73

rob73

looking for answers
HI Ronen
As always thanks for the input, i have suggested that he the contacts the manufacturer of the catheter (he is the EC rep and distributor) and find out how the product has been CE marked and if any standards were used to gain it. As for the NHS, i suspect that someone has just given the buyer a checklist of requirements without actually understanding what they are asking for.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P On-going stability study requirement for medical device US Food and Drug Administration (FDA) 2
F CQI-22 - CQI-12 Requirement for Mills IATF 16949 - Automotive Quality Systems Standard 5
R Regarding UL Certification requirement CE Marking (Conformité Européene) / CB Scheme 6
U Does Medical Device training video falls under labeling requirement ? Other US Medical Device Regulations 4
M Citing Against Requirement 7.1.4 Environment for the operation of processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 59
M Is there a mandatory requirement to notify customers of the complaint resolution in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
S AS9120 - New Internal Auditor Training requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
H Is it a requirement for run charts to have inspection data or can it have just a pass/fail check mark Records and Data - Quality, Legal and Other Evidence 4
I Brazil clinical data/trial requirement Other Medical Device Regulations World-Wide 1
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
D Packaging requirement ? EU Medical Device Regulations 0
C Isolation requirement for USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C Creepage requirement Wearable ECG IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
V IATF 16949 GM CSR 10.2.4 Error-proofing requirement IATF 16949 - Automotive Quality Systems Standard 2
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
CaliperJim Uncertainty and Accuracy Requirement Deviation Provision General Measurement Device and Calibration Topics 2
Y Software to Manage IEC 62304 Traceability Requirement IEC 62304 - Medical Device Software Life Cycle Processes 3
Ajit Basrur Where to find a pagination requirement as "Page x of y"? ISO 13485:2016 - Medical Device Quality Management Systems 7
T Logistics and 3PL regulatory requirement in India for Pharmaceuticals and Med devices Other Medical Device Regulations World-Wide 0
G ISO 9001 - when implementing customer requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
H Regarding external surface temperature limit requirement for lab incubators. CE Marking (Conformité Européene) / CB Scheme 2
H OTC DRUG Private Labelling Distributor: GMP REQUIREMENT ISO 13485:2016 - Medical Device Quality Management Systems 0
R UDI Requirement at home patient use EU Medical Device Regulations 2
L Definitions Requirement ISO 14971 - Medical Device Risk Management 10
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 4
Y Brazilian lab requirement for medical device manufacture Other Medical Device Regulations World-Wide 1
J QTC Requirement as per API 6A-21st Edition Oil and Gas Industry Standards and Regulations 1
J NADCAP Root Cause - Misinterpretation of Checklist Requirement Various Other Specifications, Standards, and related Requirements 5
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H FAI Requirement After Moving CNC Machine? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 10
E Language requirement DoC EU Medical Device Regulations 6
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 14
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
Javier Guan Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9

Similar threads

Top Bottom