SBS - The best value in QMS software

MDR Annex I chapter 23.2 (q) - Information required on the label

Wolf.K

Involved In Discussions
#1
Hi,


I try to understand the implication of MDR Annex I Chapter 23.2 (q):


The label shall bear all of the following particulars:
(q) an indication that the device is a medical device.


I think there is no symbol for medical devices, right? So, do I need to write "This product is a Medical Device" on the label? In all official languages of the EU???


? W.
 
Last edited:
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Good question! Translation being a continual challenge in the EU, we'd sooner not add additional text that is subject to translation.

I'd hope that, in practice, the totality of other items on the label (CE mark & Cert.No., NB number, Authorized Representative,...) would suffice to indicate the product is a medical device. Otherwise, without some universal symbol, it'd seem unecessarily onerous to require text as as benign as "This is a medical device", that would need to be translated into all EU languages.
 
R

ryannh

#3
I was just discussing this earlier today. I was under the impression that a symbol was going to be published similar to the IVD symbol that is in EN ISO 15223-1. Review of a BSI white paper didn't provide any clarity.

Hopefully someone closer to the action can provide some additional information. Thx
 

Wolf.K

Involved In Discussions
#4
A friend of mine knows someone how knows a lot (of people)... So I got the info, that a symbol similar to the [IVD], that is, [MD] can already be part of the label, as long as it is defined in the list with the symbols. EU regulation allows that you can create your own symbols, as long as you define them. But I was not able to find information on the font type, letter size and how thick the black rectangle around the MD letters has to be. ISO 3461 or ISO IEC Guide 74 do not proide this information?
 

Wolf.K

Involved In Discussions
#5
I have heard, that in the new ISO 15223-1 DIS there is a "MD" symbol included. Can anyone confirm this, and does anyone know when the updated standard will be published? Updating every five years might mean somewhere in 2021?
 

Marcelo

Inactive Registered Visitor
#6
Yes, the CD/DIS does have a medical device symbol, the comments will be discussed in October in London. Publication date is expected for November next year.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Hi Kreid, could you tell me where did you get this part of the table from?
I have been looking for a table of mandatory-to-appear on the label symbols according to the MDR and I was not able to find one.
The MD symbol is not mandatory, only the indication that the device is a medical device. When implemented in a compliant way, symbols are an elegant way to address label space and translation issues.
 
Thread starter Similar threads Forum Replies Date
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 1
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 2
M MDR Annex IX Chapter I, 2.2 (c) - Device identification procedures during manufacture. EU Medical Device Regulations 1
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
K Applicability of Cybersecurity EU MDR 2017/745 Annex 1 23.4(ab), 14.2(d) CE Marking (Conformité Européene) / CB Scheme 3
K Applicability of eIFU as per EU MDR 2017/745 Annex 1 23.1 CE Marking (Conformité Européene) / CB Scheme 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
S Difference between EU-MDR Annex IX and the Annex-combo X&XI EU Medical Device Regulations 2
S EU MDR Annex XIV - Clinical Evaluation Plan - What do these methods mean? EU Medical Device Regulations 13
K Annex XVI Device Transition Timeline under the MDR EU Medical Device Regulations 2
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
A EU MDR Annex I section 11.3 - Medical Devices labelled as having a specific microbial state EU Medical Device Regulations 7
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
A EU-MDR Annex I Requirement 10.1(d) EU Medical Device Regulations 3
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
D Example for Accessories of "Annex XVI non-medical devices" and how to classify it now with respect ot EU MDR Other Medical Device Regulations World-Wide 1
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
T EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) EU Medical Device Regulations 0
S MDR Annex II Design & Manufacturing info - 'Adjuvants' definition EU Medical Device Regulations 3
J IVDR and MDR ANNEX I Requirements Template EU Medical Device Regulations 5
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
R MDR & depth of review by NB's EU Medical Device Regulations 7
U EU-MDR: complicated supply chain EU Medical Device Regulations 2
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Medical Device and FDA Regulations and Standards News 0
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 1
S Classification of a product according to MDR EU Medical Device Regulations 3
L Classification under MDR EU Medical Device Regulations 1
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
S Converting SOP MDD to MDR Noob ISO 13485:2016 - Medical Device Quality Management Systems 4
K Biological indicator system classification under MDR EU Medical Device Regulations 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
J EU MDR getting closer - Special offer for Elsmar members 10/2020 EU Medical Device Regulations 14
G MDR translation requirements EU Medical Device Regulations 3

Similar threads

Top Bottom