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
Staff member
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
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
H Using/Selling power banks with your product as a "mobile version" CE Marking (Conformité Européene) / CB Scheme 3
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
B Design Responsibilities for Mature Acquired Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 3
D Dental application - medical product or not? Other US Medical Device Regulations 8
Q Product Quality vs Product Defects Manufacturing and Related Processes 4
J Verification of purchased product / supplier questionnaires ISO 13485:2016 - Medical Device Quality Management Systems 2
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Product Code 510(k) exemption US Food and Drug Administration (FDA) 1
M REACH assessment of PCBA/finished product REACH and RoHS Conversations 2
J Validity of CE mark on distributed product when company ceases trading EU Medical Device Regulations 3
Q News cradle to grave - Product life cycle ISO 14001:2015 Specific Discussions 5
J Using of CE marking - Two CE markings on the product CE Marking (Conformité Européene) / CB Scheme 5
W Final Report re: Market withdrawal of radiation-emitting product Other US Medical Device Regulations 0
M Combination Product - New MAA EU Medical Device Regulations 0
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
Z REACH compliance for low volume product REACH and RoHS Conversations 1
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
H Verification Process for the existing MDS Product IEC 62304 - Medical Device Software Life Cycle Processes 5
A UDI for product already packed up EU Medical Device Regulations 0
A Migrating from whole product CE marking to modular approach CE Marking (Conformité Européene) / CB Scheme 5
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
lanley liao Are there guidelines for application of all API monogrammal product? Oil and Gas Industry Standards and Regulations 2
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
William55401 Distributed By Product - Best Practices for Configuration Management and Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 0
R Compatibility studies - combination product CE Marking (Conformité Européene) / CB Scheme 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
dinaroxentool Selling a product in Both UK and EU after Brexit UK Medical Device Regulations 9
P EU MDR Translation of Product Name EU Medical Device Regulations 3
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
Sidney Vianna Informational APQP4Wind - Advanced Product Quality Planning for the Wind Power Supply Chain APQP and PPAP 3
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 12
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
D Classification of product for clinical trials EU Medical Device Regulations 14
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6

Similar threads

Top Bottom