Can a product be reviewed and CE Marked in accordance with ISO 15197:2013

M

missjenny

#1
Hi everyone,

Can a product be reviewed and CE certified in accordance with ISO 15197:2013 rather than 2003 right now? My notified body is saying it is impossible as it has not been harmonized yet, but I hear rumors that some notified bodies are certifying blood glucose meters (BGMS) with the 2013 standard version.

Thank you.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Leader
Moderator
#2
Re: How to guess when the standard gets harmonised?

See here

You probably misinterpreted their statement. You can use whatever published standard you wish, or no published standard at all, in support of the ER being met; It's just that you will have to justify how your alternative methods are satisfying the ER (rather than rely on the "automatic" presumption of conformity conferred by following a harmonized standard).
 

pkost

Trusted Information Resource
#3
If you were to seek approval using the 2013 standard, I would recommend producing a report comparing it with the harmonised standard and identifying the differences. where differences occur you will need to justify why it is still in conformance with the essential requirements
 
Thread starter Similar threads Forum Replies Date
sonflowerinwales Outgassing - product inside a sealed housing Manufacturing and Related Processes 1
L Temporary Product Deviation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
FRA 2 FDA Product NCRs- Quality Review Nonconformance and Corrective Action 6
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Aftermarket product PPAP approval IATF 16949 - Automotive Quality Systems Standard 1
G How to find applicable standards for a new product? EU Medical Device Regulations 3
T Link GMDN code and FDA product code US Medical Device Regulations 5
S Combination Product - Packaging US Food and Drug Administration (FDA) 6
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
H Regarding EMC & Safety retesting requirements of the product CE Marking (Conformité Européene) / CB Scheme 2
Q Product audit assessment IATF 16949 - Automotive Quality Systems Standard 3
S Submit under a new product code in a 510k? US Medical Device Regulations 5
P Product Quality Review API-GMP Manufacturing and Related Processes 0
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
A Product Update and executing only affected System Tests, leaving out unaffected ones IEC 62304 - Medical Device Software Life Cycle Processes 5
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
M How to show the effect of the failure mode on the manufacturing process as a customer of product design process? FMEA and Control Plans 3
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1
B Product registration CE Marking (Conformité Européene) / CB Scheme 2
V Product naming: Same name - different perfume & status CE Marking (Conformité Européene) / CB Scheme 0
E Marketing, product and system requirements IEC 62304 - Medical Device Software Life Cycle Processes 2
C PPAP requirements for consumer product APQP and PPAP 2
C How to place software version for SaMD product in HIBC secondary data structure (UDI-PI)? Other US Medical Device Regulations 3
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
S Classification of product (measuring or not?) CE Marking (Conformité Européene) / CB Scheme 5
Ron Rompen 4.4.1.2 Product Safety Compliance IATF 16949 - Automotive Quality Systems Standard 29
M Supplier Control for Unique Product ISO 13485:2016 - Medical Device Quality Management Systems 6
R Shelf life of product Other Medical Device Related Standards 4
D One Software as Medical Device product or two? EU Medical Device Regulations 4
J Aerospace Product Key Characteristics AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F Product classification according to the 60601-2-57: Particular requirements [...] of non-laser light sources [...] IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
M Reworking MDD product w MDR labeling CE Marking (Conformité Européene) / CB Scheme 5
D Regulations covering Sterile product shipments ISO 13485:2016 - Medical Device Quality Management Systems 1
M R&R Studies - how many? per product? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
S Reliability issue - Frequent component failure of the product Reliability Analysis - Predictions, Testing and Standards 0
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L How to deal with the model number symbol for X-RAY PRODUCT Other Medical Device Related Standards 1
B Establishment and Product Registration Procedure - UK & EU UK Medical Device Regulations 0
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
M Process & Product Characteristic in Control Plan FMEA and Control Plans 17
L 1 product multiple factories EU Medical Device Regulations 0
C Product Lifetime on Labeling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
P API Q1 - Monogram Product & API 4F - Proof Load Test Oil and Gas Industry Standards and Regulations 3
R CE marked product sold in UK no EU rep CE Marking (Conformité Européene) / CB Scheme 2
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
Awais How to mistake proof - Shipping Orders with Shortages - Product Quantity Accountability mismatch with Job Traveller? Manufacturing and Related Processes 17
L Product and process Deviation procedure Manufacturing and Related Processes 1

Similar threads

Top Bottom