Is there and OBL and OEM Contract Template?

C

controlz

#1
We import a range of own-label medical devices from China. These are legitimately CE marked by the the factory and comply with the MDD Directive. We ensure that we are supplied with all Declaration's of Conformity along with the technical files and any other relevant documentation that is available. We make no changes to the products whatsoever apart from have the factory print our logo onto the top and print our own box when necessary.

Whilst by law we become the 'manufacturer', we have been informed that we don't actually need to compile our own technical files or declaration of conformity since these would be identical to that of the OEM. We have been advised however to draw up a basic contract between ourselves and all our factories stating that they agree to keep us informed of any product changes / changes to the declaration and to confirm that all documentation is legitimate.

I assume this is a widely-used contract and hoped there was a basic template available, or if not could you be so kind as to advise of some of the points it must contain, as I plan on compiling it myself.
 
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RobertvanBoxtel

Involved In Discussions
#2
There are many examples for these contracts. Feel free to google me and get in contact through MD Project BV.
FYI, there is a lot more than only the items you identify that need to be covered. To be able to apply yourself for CE (Are you really the manufacturer identified?), you need to establish a QMS that meets the requirements of the MDD.
For the evidence in the OBL Dossier, make sure you gather at least:
CE / DE / TE certificate(s) of OEM product
  • ISO certificates of OEM manufacturer and where applicable sterilization suppliers.
  • DOC OEM
  • Draft DOC OEM
  • Product descriptions with claims, indications etc.
  • IFU OEM products and draft IFU OBL
  • Comparison list between OBL-OEM
  • Flowchart manufacturing
  • Last audit report NB of OEM
  • Content page of Technical File or DHF
  • Quality agreement
  • Clinical evaluation report of OEM product (typically only in case of Class IIb / III).
So, lot's to do. And pick a Notified Body that will survive the ongoing shake down as a result of increase scrutiny.
 
C

controlz

#3
There are many examples for these contracts. Feel free to google me and get in contact through MD Project BV.
FYI, there is a lot more than only the items you identify that need to be covered. To be able to apply yourself for CE (Are you really the manufacturer identified?), you need to establish a QMS that meets the requirements of the MDD.
For the evidence in the OBL Dossier, make sure you gather at least:
CE / DE / TE certificate(s) of OEM product
  • ISO certificates of OEM manufacturer and where applicable sterilization suppliers.
  • DOC OEM
  • Draft DOC OEM
  • Product descriptions with claims, indications etc.
  • IFU OEM products and draft IFU OBL
  • Comparison list between OBL-OEM
  • Flowchart manufacturing
  • Last audit report NB of OEM
  • Content page of Technical File or DHF
  • Quality agreement
  • Clinical evaluation report of OEM product (typically only in case of Class IIb / III).
So, lot's to do. And pick a Notified Body that will survive the ongoing shake down as a result of increase scrutiny.
Robert, thanks for this detailed reply. Unfortunately what you have mentioned is rather confusing and I'll tell you why:

I've spent most of the day on the telephone to the MHRA, which as I'm sure you're aware are the UK's governing body for the MDD. None of what you have mentioned to me was discussed (bear in mind, the devices we are importing are relatively simple such as finger pulse oximeters). I was informed that provided I had easy access to all relevant documentation from the OEM, and had a basic contract in place stating we are to be kept regularly informed of changes to product, conformity or complaints, then this was sufficient. I would need to have registered with the MHRA too by filing an RG2 form.

Regarding the notified body, here is something I read in NB-MED/2.5.5/Rec 5:

Where Notified Body intervention is required, an OBL manufacturer would simply have to demonstrate to the Notified Body that he has access to the technical documentation of the original manufacturer holding the existing CE Marking approval. It has already been assessed by a Notified Body so does not have to be assessed in full again.

:frust:
 
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RobertvanBoxtel

Involved In Discussions
#4
This might come down on whether you are really identified as manufacturer on the label or as distributor only. Or maybe as EU Authorized Representative (EU AR). Only in the first case you will need to get NB involvement in case of devices Class IIa, IIb and III and in case the class I devices are sterilized or have a measuring function.
If it concerns Class I devices, and you are manufacturer, you need to register / notify the products in the country where the EU AR is located(UK? --> MHRA).
In case you are the EU AR, you need to do that on behalf of the manufacturer. Indeed in that case you need to have readily access to the files.
So it depends on the actual construction you have established.
 

pkost

Trusted Information Resource
#5
I believe (and I may be wrong) that a pulse oximeter would be class IIa, this would require you to appoint your own notified body if you intend to be declared as manufacturer.

an RG2 form for the MHRA only applies to Class I, Is and Im devices.

Information that you would have to submit to your NB for approval is (and should be maintained yourselves for Class I):
- original manufacturers DoC
- your DoC
- original manufacturers EC certificate
- original manufacturers essential requirements
- a statement that the essential requirements continue to apply to your product
- clinical evaluation
- original manufacturers artwork/claims or text
- your artwork/claims/text
- signed agreement between you and the original manufacturer that you will exchange PMS, not modify product, maintain CE marking etc etc (there are many templates dotted around)

additionally you would require to put in place:
- complaints/vigilance procedure/post market surveillance procedure,
- recall procedure


Roberts list is slightly inaccurate, the following are not necessary from a regulatory perspective, only potentially for your companies due diligence:
- Flowchart manufacturing
- Last audit report NB of OEM
- Content page of Technical File or DHF

Additionally for "Clinical evaluation report of OEM product (typically only in case of Class IIb / III)"...Clinical evaluations are required for all classes of products, although I do acknowledge that a lot of manufacturers forget/can't be bothered for lower classes
 

RobertvanBoxtel

Involved In Discussions
#6
The listing provided is a good overview of expectations from Notified Bodies. It turns out to be very much also depending on the NB used by the OEM
It depends on the NB what they want to see, and I have been requested to provide the information, again depending on NB.
Clinical evaluations are indeed required for all devices. But the NB of the OBL only requests those (personal experience) in case of the higher risk devices, to make sure a proper evaluation is performed by the OEM and the NB involved.

By now, you should have all the ingredients to write a complete TD for OBL-OEM devices.
 
C

controlz

#7
Thanks for all of the advice.

I know this sounds ridiculous, but the example of a finger pulse oximeter is an incredibly popular item that's being sold all over eBay and Amazon under a plethora of OBL's (despite the actual devices being the same). In reality I can't imagine ANY of these sellers have gone through this entire process - it just seems like a huge amount of effort. I'm talking about large businesses too.

Is it more common than not that the majority of OBL's will try their utmost to ensure they comply with all parts of the MDD, but in reality it's rarely completed in full, and if an audit was to take place it's likely they would be respected for their effort, and assisted in following the MDD more closely as opposed to prosecution?

I ask this because the oximeter is only a very small part of our business, and it seems like a considerable amount of time and effort needs to go into compliance that probably wouldn't be recouped from sales. (And this is all only because we are selling under our own name as opposed to the OEM's (when the product is identical)
 

pkost

Trusted Information Resource
#8
online purchaing of medical devices is notorious for non compliant, poor quality devices, in fact only the other week the MHRA issued a safety notice relating to dental instruments bought online (http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON369252?tabName=Problem).

I certainly wouldn't condone the marketing of inappropraitely CE marked products, there are plenty of honest businesses out there that take the time and effort to comply and ensure the safety and efficacy of their products.

If you are looking for a quick and simple route to market for your product, with your name on it, then you could consider licensing your brand to the origninal manufacturer (with appropriate restrictions); they can then apply your brand and declare themselves as manufacturer and sell you the product for you to act as a distributor. Don't forget to add the EC rep to the packaging if they are outside of the EU though

With regards to enforcement action, the level of non compliance would be considered, if there was no legitamate CE mark then they would likely receive a letter telling them to comply followed by a progressively more agressive stance leading to fines.

If a CA/NB had seen efforts to comply, i.e they had notified the CE of their intention to market (for class 1); had certain technical file aspects in place, then the manufacturer would be given time to correct the issue (unless there was a safety risk)...Continued non compliance would result eventually in fines
 
C

controlz

#9
Pkost - You're a star, thanks for the quick response.

Our devices certainly aren't poor quality (as I mentioned we do considerable duedil on factories and ensure we have all documentation prior to importation) so I'm certainly not concerned about the safety of our products. I've joined this forum to try my utmost to be 100% compliant and as a genuine business have no intention to be noncompliant :agree1:

I imagine the main reason for bodies such as the MHRA is to ensure the safety of devices sold, and I have every bit of confidence in what we distribute...

Moving that aside, we also sell a range of basic OBL LVD devices for home-use. Is compliance a lot more simple than MDD and simply require what I had written in my original post (direct access to OEM documentation and a basic OBL/OEM contract) ?

:thanx:
 

somashekar

Staff member
Super Moderator
#10
Hi controlz ...
There is no shortcut to regulatory
Size of business and regulatory are independent of each other. They do not interact.
See Own Brand Labelling from the MHRA
As a small tip, working with the NB of the OEM may make your OBL process easier
pkost suggestion of licensing is an other way. We do that. Try it.
Finally what matters is business and regulations covered adequately
 
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