Harmonized standards vs. EN ISO References

missjenny

Involved In Discussions
#1
Hello,

We manufacture blood glucose meters and test strips. As such, the newly minted/harmonized EN ISO 15197:2015 is the primary applicable standard for our products. And in this standard is a table explaining the correlation between undated normative references and dated EN and ISO standards. The problem is instead of listing harmonized standards, the table lists the latest versions of the standards. Now, in order to declare conformance to EN ISO 15197:2015, which is harmonized and compulsory, do we have to conform to the latest standards listed in the table as well?

While all of our products comply with the harmonized standards, some of our products have not been tested with the latest versions of these standards. Can we use EN ISO 15197:2015 for Declaration of Conformity in this situation?

For example, IEC 61326-2-6:2006 is harmonized but EN 61326-2-6:2013 is listed in EN ISO 15197:2015.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
EN ISO 15197:2015, which is harmonized and compulsory
Why do you state that it's compulsory? Harmonized standards are generally never compulsory.

Now, to address your questions - if you want to claim compliance with a harmonized standard, and that standard references the latest revision of another standard (either explicitly or by omitting the year, which normally means that you must adjust to the latest published version), you must comply with that latest revision, whether it's harmonized or not. This in turn is not an absolute obligation, but it is required if you want to benefit the presumption of conformity.

In any other case you would have to justify that the adopted solution (ie compliance with an older version, either harmonized or not) suffices to show compliance with the relevant Essential Requirements. To that end I recommend that you perform a gap analysis between the two versions - the older one that you comply with vs. the one that the current harmonized standard references - and justify why the identified gaps in testing (or otherwise) are insignificant in terms of Essential Requirements compliance.

I hope I didn't complicate it too much :)

Cheers,
Ronen.
 

missjenny

Involved In Discussions
#3
Hi Ronen,

Thank you so much for your explanation. It was really helpful.

Just one more question though, if we perform a gap analysis between the two versions, do we list the new or the old one that we comply with in the Declaration of Conformity?

Stephen
 
Thread starter Similar threads Forum Replies Date
F ISO 10993-10 - Removed from List of Harmonized Standards Other Medical Device Related Standards 4
N Harmonized Standards for MDR Certification EU Medical Device Regulations 6
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 8
M EU Harmonized Standards - Withdrawals and Replacements EU Medical Device Regulations 14
D EU Harmonized Standards to which a company has declared compliance EU Medical Device Regulations 13
Q Compliance to EU Official Journal Harmonized Standards (MD/IVD products in EU) EU Medical Device Regulations 7
A 93/42/EEC Declaration of Conformity and Harmonized Standards EU Medical Device Regulations 12
Marc MDD Harmonized List of Standards Website Moved Other Medical Device and Orthopedic Related Topics 1
W New list of MDD Harmonized Standards Other Medical Device Related Standards 2
D Harmonized Standards EN vs. IEC CE Marking (Conformité Européene) / CB Scheme 11
R No Stability Standard on latest List of Harmonized Standards IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
S Annex Z of Harmonized Standards EU Medical Device Regulations 3
P Retrospective Application of EN 60601-1:2006 - Harmonized Standards IEC 60601 - Medical Electrical Equipment Safety Standards Series 27
O Harmonized Standards on Medical Device IFU (Instructions for Use) ISO 13485:2016 - Medical Device Quality Management Systems 7
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
E Types of Standards and Harmonized Standards Other ISO and International Standards and European Regulations 6
xcanals_tecno-med.es Revised list of harmonized standards for medical device directives in the EU (7/7/10) EU Medical Device Regulations 0
R Medical Device: New List of Harmonized Standards in EU under MDD93/42/EEC EU Medical Device Regulations 6
M Revised list of harmonized standards for medical device directives in the EU EU Medical Device Regulations 1
W New Harmonized Standards MDD and IVDD EU Medical Device Regulations 5
S EC Official Journal Harmonized Standards - Additional requirements? ISO 13485:2016 - Medical Device Quality Management Systems 3
W New List of Medical Device Harmonized Standards - MDD CE Marking (Conformité Européene) / CB Scheme 5
A List of Harmonized Standards for the MDD, IVD and IMDD - June 2006 ISO 13485:2016 - Medical Device Quality Management Systems 5
amjadrana CE Mark & Harmonized Standards EU Medical Device Regulations 8
Y Retroactive application of harmonized standards US Food and Drug Administration (FDA) 2
Y CE Mark & Harmonized Standards - Article 5.1, MDD - Has anyone challanged this? EU Medical Device Regulations 5
G Harmonized List - MDD 93/42/EEC Other ISO and International Standards and European Regulations 2
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
R Information on the roll out of the new harmonized DRAFT FMEA AIAG/VDA manual IATF 16949 - Automotive Quality Systems Standard 4
M EN Standard (ETSI EN 301 489-3 v1.6.1) is Harmonized but not on Europa List Other ISO and International Standards and European Regulations 3
M Harmonized EN 60601 Z Annexes are Not Useful IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A Is ISO 14644 harmonized for US? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
O Harmonized standard of EU---EN 60601-2-10:2000/A1:2001 EU Medical Device Regulations 1
M Labelling and the harmonized EN ISO 14971:2012 ISO 14971 - Medical Device Risk Management 9
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
AnaMariaVR2 Documentation and Records: Harmonized GMP Requirements Document Control Systems, Procedures, Forms and Templates 1
AnaMariaVR2 IMDRF Working With ICH on Harmonized Electronic Submission System for Drugs, Devices Other Medical Device Regulations World-Wide 0
T Harmonized Standard Compliance Question EU Medical Device Regulations 5
J When will EN 60601-2-4:2010 be harmonized? EU Medical Device Regulations 3
W EN ISO 15225 (2010) - Medical Device Nomenclature - A Harmonized Standard? EU Medical Device Regulations 1
T When will ISO 13485 be updated? Will it be harmonized with ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 4
T HTS (Harmonized Tariff Schedule) and "12 NC" Codes for Products RoHS, REACH, ELV, IMDS and Restricted Substances 3
T Which Harmonized Standard to which Essential Requirement EU Medical Device Regulations 3
J EN 93/42 revised draft (harmonized) - Medical Devices Various Other Specifications, Standards, and related Requirements 1
Q Help with Schedule B Harmonized Codes Various Other Specifications, Standards, and related Requirements 1
W EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
P Citing EN standards Other Medical Device Related Standards 6
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6

Similar threads

Top Bottom