SBS - The best value in QMS software

IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks?

M

MPiska

#1
Hi All,

A discussion has come up with our HS&E officer on the hazard labelling of products and information we need to show on primary, secondary and within the IFU.

He, naturally, refers back to the CHiP and "new" CLP regulations and states that we must show the symbols, phrases, and then supplementary statements etc. etc.
We are including all relevant symbology and information on the outer packaging and in the IFU however due to the size of our products there is no feasible way of doing this on the primary labelling without using the peel/fold labels - which are accounted for in the regulations and he says that we must use them going forward.

Essential Requirement 8.3 of the IVDD states

In the case of devices containing or a preparation which may be considered as being dangerous,
taking account of the nature and quantity of its constituents and the form under which they are
present, relevant danger symbols and labelling requirements of Directive 67/548/EEC (1) and
Directive 88/379/EEC (2) shall apply. Where there is insufficient space to put all the information
on the device itself or on its label, the relevant danger symbols shall be put on the label and the
other information required by those Directives shall be given in the instructions for use.


The provisions of the aforementioned Directives on the safety data sheet shall apply, unless all
relevant information as appropriate is already made available by the instructions for use.
This "get out clause" is still included in the upcoming IVDR, and makes explicit reference to the CLP regulation.

My question is, does this 'get out clause' entirely outrank the requirements of the relevant hazard labelling regulations?

Many Thanks

MP.
 
Elsmar Forum Sponsor
R

Ron Boumans

#3
Don't use that 'get out clause' too easily!

Be pragmatic: sometimes devices or parts are just too small to put symbols on them. Even the packaging of parts can sometimes be too small for practical use for symbols. In those cases we usually see a bulk packaging with enough space for clear warnings and information. But it also happens that most of the space on a label or device is taken for logo's and commercial information ("New design!") That is - of course - no excuse for leaving the warnings off the label.

Besides, there is allways the risk analysis. If there is a risk identified that should be addressed by a warning, that warning should be placed on an appropriate location so that the user can get this information at a relevant moment. And that is exactly what essential requirement 8.3 of the IVDD is about.
 
Thread starter Similar threads Forum Replies Date
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
B EU: Alcohol test kits for breast milk IVDD EU Medical Device Regulations 2
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
P Performance evaluation (IVDD Annex VIII) & Design and Development Validation Studies EU Medical Device Regulations 1
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
P IVDD - IFU related requirements - Type of information/statement expected EU Medical Device Regulations 1
L IVD Reagent Techncial File Review Requirements (IVDD Annex III) EU Medical Device Regulations 4
X Algeria IVDD Registration Requirements in English Other Medical Device Regulations World-Wide 2
C IVDD 98/79/EC Measuring Function Requirements EU Medical Device Regulations 2
L IVDD 98/79/EEC - Can I self declare? EU Medical Device Regulations 2
P Proposed Changes to the Medical Device Directive (and IVDD) EU Medical Device Regulations 0
W New harmonised standards MDD and IVDD 2012/C 262 EU Medical Device Regulations 4
D IVDD RoHS Directive Compliance to 2011/65/EU RoHS, REACH, ELV, IMDS and Restricted Substances 4
R No Stability Standard on latest List of Harmonized Standards IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
I IVDD - Software and Graphics Standards or Guidance Documents EU Medical Device Regulations 3
W New Harmonized Standards MDD and IVDD EU Medical Device Regulations 5
W EN ISO 13485:2003 harmonized to AIMD, MDD and IVDD ISO 13485:2016 - Medical Device Quality Management Systems 2
I Hazard Identification and Naming ISO 14971 - Medical Device Risk Management 10
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
D Failure rate vs hazard rate vs rate of failure Reliability Analysis - Predictions, Testing and Standards 2
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
M Informational Work in progress at the FDA for biological evaluation – Color Hazard and RISk calculator (CHRIS) Medical Device and FDA Regulations and Standards News 0
A Fire hazard classification - Clause in IEC 60601 about gauze and electricity ISO 14971 - Medical Device Risk Management 0
N Should it even be on the hazard analysis (software)? FMEA and Control Plans 2
S ISO 14971 Risk Management - Questions for Hazard identification ISO 14971 - Medical Device Risk Management 2
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
A Risk-benefit Analysis - Hazard Analysis (HA) and FMEAs ISO 14971 - Medical Device Risk Management 18
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
D Hazard analysis for our medical device - Hazards seem to overlap 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
F Medical Device HACCP (Hazard Analysis and Critical Control Point) Risk Management ISO 14971 - Medical Device Risk Management 2
L No entanglement hazard of applied parts cables? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1
E EN/UL/CSA 61010 -1 (ed3) Safety and use of Software to Prevent Electrical Hazard CE Marking (Conformité Européene) / CB Scheme 3
M Hazard Identification for Pest Control Activities Other ISO and International Standards and European Regulations 9
N Hazard Probability of Occurrence Definition ISO 14971 - Medical Device Risk Management 11
A ISO 14971 Figure E.1 that starts with Hazard and ends with Risk ISO 14971 - Medical Device Risk Management 3
R Risk Analysis and Hazard Identification concerning Clinical Decision Support Systems ISO 14971 - Medical Device Risk Management 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
R Risks which must be Distinctly Identified - Harm, Hazard, Severity ISO 14971 - Medical Device Risk Management 7
S Hazard Identification and Risk Assessment - Can Risk Assessment be "Grandfathered"? Occupational Health & Safety Management Standards 4
2 Medical Device Hazard Risks - Normal Use Risks vs. Faulty Use Risks ISO 14971 - Medical Device Risk Management 4
K Regarding ISO 62304 Clause 7.3.3 - Hazard and Risk Controls IEC 62304 - Medical Device Software Life Cycle Processes 9
S PMA Submission Software Hazard Analysis Document vs. Product Hazard Analysis doc ISO 14971 - Medical Device Risk Management 5
V FMEA vs. Process Hazard Analysis (PHA) FMEA and Control Plans 2
S Aspect vs. Impact and Hazard vs. Risk - Short/clear explanation & example Miscellaneous Environmental Standards and EMS Related Discussions 11
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Seeking guidance on Preliminary Steps to enable Hazard Analysis Food Safety - ISO 22000, HACCP (21 CFR 120) 1
K Differences between "Hazard" and "Risk" in ISO 22000 Food Safety - ISO 22000, HACCP (21 CFR 120) 4
K General HACCP (Hazard Analysis Critical Control Point) Questions Food Safety - ISO 22000, HACCP (21 CFR 120) 8

Similar threads

Top Bottom