MDR language requirements

Billy Milly

Involved In Discussions
#11
I am tending to agree a bit more :) I also enjoy the discussion.

I reviewed some more elements of Annex II and it seems it allows for some cherrypicking. If it would not, it would be very difficult to address everything.

I fully agree with your last opinion - if IFU is not supplied, there are not much requirements related to the content left.

About requests for IFU: This was an (old) explanation from our CA. Maybe this was their own interpretation as I cannot find anything relevant in the MDR. IFU ("as a document") is also mentioned in Annex II, 2 (it is expected in the tech file), but as you wrote, content if the IFU is only specified for cases where IFU is supplied. Maybe this route is the reason for all shady IFUs out there :)

Honestly, I never dived really deep in this topic as our products require an IFU in all cases. Thank you for this.
 
Elsmar Forum Sponsor

EmiliaBedelia

Involved In Discussions
#12
The reference is correct but the consequence is not. Device labels and IFUs are both part of the accompanying information. Article 10(11) just allows the member states to require whatever language they want for this. In the case of Germany, for professional users any easily understandable language is acceptable. Safety related information shall be in German or in the language of the user (probably German). Thus, if your device is intended for professional users only and you do not have any safety related information (in English) on your label, you may place the device on the market in Germany without further translation activities.
Agreed that for Germany in particular you may not need to translate for professional users. My point here is that the exception for safely using without an IFU (per GSPR 23.1) would not extend to the label - so there may be a reason why translation per Art. 10 is not required for a particular country, but it's not the same exemption that would apply to the IFU.

Also, the original poster never confirmed if the device is for professional users or not...so that exemption may not actually be applicable to them. The bottom line is that the OP would need to verify for individual countries whether they will accept English-only, there is no exemption for labels inherent in the regulation.
 

RA_QA_Expert

Involved In Discussions
#13
Hi Everyone,

We have a MDR devices (Class I and Class IIa that does not have IFU because it can be used without IFU. (Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section. )
The labels have only English and providing an image of the device on the label.

We are planning to sell the product in Spain and Germany. Do we need to translate labels to the languages of member states where the product is going to be sold?
Or picture is enough on label. Is there any regulations that mentioned some exceptions for Labeling. Thank you.
Hello,
if you justify that you do not need IFU for your class I / IIa device, this justification must be based on risk/usability evaluation. But if you have some residual risks, or user needs to be instructed for proper device usage without user errors, such information must be provided with a device.

Any safety instructions must be in the understandable form for specified users. As guide you can use EN ISO 20417, there is also reference table between standard requiremens and GSPR's.

You can use normative symbols (e.g. based on ISO 15223-1, EN 60601-x, ...), and if the standard is harmonized with the applicable law (MDD within transitional period or MDR) you don't need to explain it.

if you have your own pictures or symbols, you need to evaluate its understandability within usabiilty process.

If you use any text, it must be translated into local language, or you must be sure and justify e.g.that medical professionals using your device have education to understand e.g. EN text. If you sell the device for home use and/or used1 by lay personell, there is no excuse, it must be in local language.

Good luck
 
Thread starter Similar threads Forum Replies Date
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
M EU MDR language-Translation requiremens CE Marking (Conformité Européene) / CB Scheme 8
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Experation date EU Medical Device Regulations 1
C MDR vs CMDR EU Medical Device Regulations 4
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 16
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
M EU MDR (GSPR Checklist) consolidated with TGA EP Checklist EU Medical Device Regulations 5
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G MDR DRAFT DoC EU Medical Device Regulations 7
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6
N MDR requirments EU Medical Device Regulations 0
O MDD products under MDR certificate EU Medical Device Regulations 12
I Where to find MDR compliance device? EU Medical Device Regulations 6
J Conformity assessment route options under the UK MDR 2002 (2002 SI No. 618), as amended UK Medical Device Regulations 1
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
M MDR Legal requirements EU Medical Device Regulations 6
Ed Panek MDR Audit Comment EU Medical Device Regulations 9
J Minor / Major findings with MDR EU Medical Device Regulations 4
R MDR Clinical Evaluation Plan EU Medical Device Regulations 6

Similar threads

Top Bottom