MDD 2007/47/EEC - Medical Device Directive Labeling Changes

M

melvin345

#21
I work for a medical device company that sells dental products. We have agreements with distributors that they can sell our products to different countries. Some are located in the EU as well as other countries. Their names are listed at the top of the label as the distributor and ours is located at the bottom as the Manufacturer. We keep the technical files and have a CE mark and 510k for the products. We develop some products exclusively for them and others are universal. We only use our CE mark on the label, but the distributors will sometimes re-name our product and assign new part numbers. We maintain our brand name, but the line of products they offer is given a different name with our products being included in that line. Are they supposed to use their CE mark and are we considered to be a private labeler for them? Some distributors want to place other certifications on their labels that we create to sell in other countries that require them such as Russia, but they are using our CE mark, is that acceptable?
 
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Michael Malis

Quite Involved in Discussions
#22
Hi,
from regulatory point of view, if software a device itself or it is part of the device, and if you can't use symbols, you have to tranlsate it in the Italian language and in all the European languages where you sell the software.

I'm italian and I know that probably not too many controls will be done to check the software language requirements, but it could happen that some professionals users can ask for the User manual and the information on the software in italian language. Please consider that lots of italian people don't speak english well and they could require it even just for their own understanding. So this is , also, a marketing point of view.
Let me know if you may need furthe information
Bye
Carlo
Hi Carlo,

I used example of Software Validation only - not IFU. In your example, translation is needed because you describing Instruction for Use. Also, Italy is part of the EU and symbols use and accepted widely.

Hope this helps,
Mike
 

Michael Malis

Quite Involved in Discussions
#23
I work for a medical device company that sells dental products. We have agreements with distributors that they can sell our products to different countries. Some are located in the EU as well as other countries. Their names are listed at the top of the label as the distributor and ours is located at the bottom as the Manufacturer. We keep the technical files and have a CE mark and 510k for the products. We develop some products exclusively for them and others are universal. We only use our CE mark on the label, but the distributors will sometimes re-name our product and assign new part numbers. We maintain our brand name, but the line of products they offer is given a different name with our products being included in that line. Are they supposed to use their CE mark and are we considered to be a private labeler for them? Some distributors want to place other certifications on their labels that we create to sell in other countries that require them such as Russia, but they are using our CE mark, is that acceptable?
Melvin,

CE mark for the product belong to Manufacturer. If distributor place other certificates on the label, how do you know that they promote a proper use for your product? Also, if someone changing product name or sell your product as part of the Kit (??) -than they potentially act as the Manufacturer and should have their own CE Mark for the use of this kit.

Regards,
Mike
 
C

CarloCat

#24
Hi Carlo,

I used example of Software Validation only - not IFU. In your example, translation is needed because you describing Instruction for Use. Also, Italy is part of the EU and symbols use and accepted widely.

Hope this helps,
Mike
Hi Mike,

thank you for your reply.
I know very well that Italy is part of EU and that symbols are used and accepted, but software validation is not enough to avoid translation.

Software validation is essential for the risk analysis , but Software itself is part of the correct use of the product and this is why it is necesary to give the right information in the language of the country where you sell the product, becuase for most of the information you can't use international recognized symbols.
Yana, also, reported in the above post the language requirements that the European CA require.

Tx,
Carlo
 
C

CarloCat

#25
I work for a medical device company that sells dental products. We have agreements with distributors that they can sell our products to different countries. Some are located in the EU as well as other countries. Their names are listed at the top of the label as the distributor and ours is located at the bottom as the Manufacturer. We keep the technical files and have a CE mark and 510k for the products. We develop some products exclusively for them and others are universal. We only use our CE mark on the label, but the distributors will sometimes re-name our product and assign new part numbers. We maintain our brand name, but the line of products they offer is given a different name with our products being included in that line. Are they supposed to use their CE mark and are we considered to be a private labeler for them? Some distributors want to place other certifications on their labels that we create to sell in other countries that require them such as Russia, but they are using our CE mark, is that acceptable?
Dear Melvin the situation is a bit confusing.
Labeling:
If you are manufacturer you must compare clearly on the label with the name of your European representative as required by the European directive (compulsory). If distributors want to be present on the labels, their name must be clearly stated as : "distributed by"and the dimension of the distributor name should be smaller than your company name. Be really carefull on that.EDMA have good q&a documents that well address this matter, but consider that you are, also, responsible for labeling.

Different name.
If you are manufacturer, your distibutor can change name of the product, just if :
- you agreed it and if you have included this name and part numbers change in a quality agreement with your distributors. This is why is essential that traceability for vigilance and surveillance are guaranteed by the Manufacturer (you). Distributors are not directly mentioned in the European directives.
- you included all the variants of the products in your Technical File
- you or your Europeana representative notified (registered) the product to the national CA instead of you.

I don't know exactely the situation , but I suppose that it would be better for you if distributors compare as manufacturer.It is not complicated if Notified Bodies are not involved in the CE mark assesment.

What kind of different certifications are they talking about? what is the russian certification required?

Give us some more detailed information.
tx,
Carlo
.
 

Peter Selvey

Staff member
Super Moderator
#26
Wow, what a long and complex thread! I think with respect to language, Chris touched on the key point which is Article 4, Section 4 of the directive.

As many would know, the MDD itself is not law, but there is an EU requirement that all national laws must be the same as the directive, unless the directive specifically allows local variation. This is a process called "transposition". This means for the most part, you don't need to read the national laws, since the MDD must be the same. Which is fortunate because real law can be messy.

But Article 4.4 does allow variation for language. What this means is that your only choice is to go and read the law in each country. Yes, some groups have tried to provide a summary, but these are fairly high level and can be wrong.

For example, the UK transposition of the MDD (see part 2, Section 9) says that as long as the outer packaging identifies what language the instructions are in, any EC community language is OK. So, contrary to expectations, English is not actually required in the UK (of course, read and check the law yourself before making any decisions). The German Medical Device Law (MPG) seems to be more strict.

To understand how these laws would apply to software, or for devices offered for sale on the Internet, you really need to look at the wording of each law. For this you may have to rely on your local suppliers, because the law may not be easy to find or may need translation.

So you will need a translator to know what you need to translate.:biglaugh:
 
A

Aqeel Abbas

#27
We are single use medical deviceanufacturer. I need to know where can I get cost effective tranlsation services for medical device terminology? Does someone have a better idea? :thanx:
 
C

Critical Care

#28
SectionNew RequirementY/NIf “Yes”, how addressedIf “No”, not applicable justification/rationaleor n/aArt. 1Is the product software intended to be used specifically for diagnostic &/or therapeutic purposes, intended to be used for the purpose of – Sect. 2aDiagnosis, prevention, monitoring, treatment etc.? If so, is this product now covered as a medical device? Art. 1Is the device intended to be used in accordance with both the Medical Devices Directive (MDD) and the Personal Protective Equipment (PPE) Directive? Sect 6If so, is Annex I of 89/686/EEC also met? Art. 3 2nd paraDoes the device also fall under the term “machinery” per Article 2(a) of 2006/42/EC? If so, is Annex I of 2006/42/EC met where more specific that the Essential Requirements of the MDD? Art. 12Does Article 12 apply? (systems & procedure packs) If so, is conformity assessment procedure Annex II or V (only) used? Art. 14Is the Manufacturer outside the EU? Sect. 2If so, has a single Authorised Representative been designated in the EU? PART 2 - Essential RequirementsE.R.Additional/Revised RequirementY/NIf “Yes”, how addressedIf “No”, not applicable justification/rationaleOr n/a1.Has risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used been reduced as far as possible? (design for patient safety) Has consideration been given to the technical knowledge, experience, education and training & where applicable the medical and physical conditions of intended users? (design for lay, professional, disabled or other users)6aDoes demonstration of conformity with the essential requirements include a clinical evaluation in accordance with Annex X 7.1Has biophysical or modeling research been used in relation to chemical, physical &/or biological properties? If so, has their validity been demonstrated beforehand? 7.5Has attention been given to substances which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I of 67/548/EEC (classification packaging & labeling of dangerous substances)? Does the device or parts of the device administer &/or remove medicines, body liquids or other substances to/from the body? Or does the device transport & store such body fluids or substances?If so, do these devices contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex I 67/548/EEC? If so, are these devices labeled on the device itself &/or on the packaging for each unit, or where appropriate on the sales packaging, as a device containing phthalates? Does the intended use of such devices include treatment of children or treatment of pregnant/nursing women? If so, is there a specific justification for the use of these substances with regard to compliance with this particular essential requirement, within - the technical documentation- the IFU? Is there information on residual risks for these patient groups, and if applicable, on appropriate precautionary measures? 12.1aDoes the device incorporate software or is it medical software? If so, is the software validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification? 13.3bDoes the label bear the details strictly necessary for the user to identify the device and the contents of the packaging especially for the users? 13.3fIs the device indicated for single use? If so, is this indication consistent across the Community? 13.6hIf the device is for single use, does the IFU provide information on know characteristics and technical factors that could pose a risk if the device were to be re-used? If no IFU is needed (ER 13.1), can the information be made available to the user upon request? 13.6qDoes the IFU have a date of issue or the revision? Part 3 Conformity Assessment Annex II or VSectionNew RequirementY/NIf “Yes”, how addressedIf “No”, not applicable justification/rationaleor n/a2, 2nd paraDoes the Declaration of Conformity cover one or more medical devices manufactured, clearly identified by means of product name, product code or other unambiguous reference? 3.1Do you undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X? ANNEX II ONLY3.2Please supply the corresponding documentation, data and records arising from the procedures for monitoring and verifying the design of the products If this has already been supplied, please indicate the location of the information.3.2bIs the design, manufacture &/or final inspection and testing of the products, or elements thereof, carried out by a third party? If so, please supply the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party. 5.2Please supply pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable. If this has already been supplied, please indicate the location of the information.ANNEX V ONLY3.2bIs the manufacture &/or final inspection and testing of the products, or elements thereof, carried out by a third party? If so, please supply the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party. ANNEX II or V6.1 (5.1)Is the device implantable? If so, are records maintained for a period ending at least 15 years after the last product has been manufactured? Part 4 CLASSIFICATION Annex IXSectionNew RequirementY/NIf “Yes”, how addressedIf “No”, not applicable justification/rationaleor n/a1.4Is the device stand alone software? If so, it is considered as an active medical device 1.7Is the device used in the arcus aorta, aorta descendes to the bifurcation aortae? If so, has the classification been reviewed, since these vessels are now considered part of the Central Circulatory System? 2.6Is the usage of the device discontinued in order for the device to be replaced immediately by the same or an identical device? If so, this is considered an extension of the continuous use of the device. Does this have an impact on the classification, with respect to the duration of use? Rule 6Is the surgically invasive device for transient use intended specifically to control, diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact with these parts of the body? 1st indentIf so, then the devices are in Class III. Does this have an impact on the current classification? Rule 6 3rd indentIs the surgically invasive device for transient use intended specifically for use in direct contact with the central nervous system? If so, then the devices are in Class III. Does this have an impact on the current classification? Rule 7Is the surgically invasive device for short tem use intended specifically to control, diagnose, monitor or correct a defect of the heart or central circulatory system through direct contact with these parts of the body? 1st indent If so, then the devices are in Class III. Does this have an impact on the current classification? Rule 15Is the device intended specifically to be used for disinfecting invasive devices? If so, then the devices are in Class IIb. Does this have an impact on the current classification? Rule 16Is the device specifically intended for recording of X-ray diagnostic images? Note – the rule now includes all devices, not just “non-active” ones. If so, then the devices are in Class IIa. Does this have an impact on the current classification? Part 5 CLINICAL EVALUATION Annex XSectionNew RequirementY/NIf “Yes”, how addressedIf “No”, not applicable justification/rationaleor n/a1.1Does the evaluation of clinical data (clinical evaluation) take account of any relevant harmonized standards? Does the clinical evaluation follow a defined & methodologically sound procedure? Is the clinical evaluation based on a critical evaluation of – The relevant scientific literature ORThe results of all clinical investigations made ORThe combined clinical data from literature & investigationsIf used, is the critical evaluation of relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device? If using scientific literature, is there demonstration of equivalence of the device to the device to which the data relates AND Does the data adequately demonstrate compliance with the relevant essential requirements?1.1aIs the device Class III or implantable? If so, were clinical investigations performed? If not, is there justification to rely on existing clinical data? 1.1bIs the clinical evaluation & its outcome documented? Is this documentation included &/or fully referenced in the technical documentation? 1.1cIs the clinical evaluation and its documentation actively updated with data obtained from the post-market surveillance? Is post-market clinical follow-up part of the post-market surveillance plan for the device? If not, is this justified & documented? 1.1dIf demonstration of conformity with essential requirements based on clinical data is not deemed appropriate, is there adequate justification for this exclusion? Is this justification based on risk management output – considering : The specifics of the device/body interactionThe clinical performances intendedThe claims of the Manufacturer If demonstration of conformity with essential requirements is by performance evaluation, bench testing and pre-clinical evaluation alone, is this substantiated? 2.3.5Clinical Investigations Is there a requirement to ensure that all serious adverse events are fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed?



Bingo Chico!! Enjoy my Friend !!!!!

Critical Care :applause::agree::cool:
 
J

jkim100

#29
Re: 2007/47/EEC MDD Labeling Changes

thanks MArc,
i know about pthaltaes requirment too....i am more concerned about langauge requirment. Is it madatory to have IFU and box labels in to minimum six langauges? my compnay is currently doing lot of translation and they ahve tranlsated IFUS or PIs in to Dutch if it is not available in to Dutch. i havent find it any MDD.
thanks
I know that for Medical Devices, we have limited our languages to those countries that we know we are marketing the product in question. For example, one device is being sold in the UK and Turkey. Since Turkey is not part of the EU, we do not have to translate our label or IFU in Turkish (although it could be argued that it would be a god business decision to do so).

As another example, one of our devices is being sold in the UK and Spain, so we potentially could start off just translating the labeling in Spanish, and nothing else.
 
M

melvin345

#30
Re: 2007/47/EEC MDD Labeling Changes

The risks for not translating in the countries language are seizure at border, liability as the manufacturer if the product is not used properly, possible recall, and may not be able to get liability insurance if not completing translations.
 
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