EU MDR Requirements on Equivalent devices

[Kuldeep Singh]

Hi,

As i read the EU MDR requirements and i notice there is a requirement for level of access to equivalent device data, i.e MDR requires a contract between the manufacturer and the equivalent device manufacturer to access the technical documentation of that device .Is it practically possible? I think equivalent devices are mostly competitor's devices and they are unable to share technical/clinical/biological data with us.

Please give me guidance and your thoughts on this.

 

[pkost]

I assume you are referring to Article 61 paragraph 5.

This is limited to implantable class III devices where the manufacturer does not want to conduct a clinical investigation because of the existance of an equivalent product. The lack of an agreement does not prevent the manufacturer from obtaining a CE mark, it just means the they will have to do their own clinical investigation

The requirment makes sense because the level of risk is high and how can you truly say your product is equivalent without full access to the equivalent products technical file? In reality, I suspect it will be used by multinationals who have multiple entities. I can also imagine circumstances where manufacturers that are ostensibly competitors are collaborating on a research area and may find it commercially beneficial to sign such an agreement

 

[Marcelo]

Just an addendum, it's for implantable devices AND class III devices.

Also, paragraph 5 was really created for specific cases, for example for mergers, when you need to use a device which was not previously manufactured by yourself. It's really not a generic option for equivalency.

 

[pkost]

Marcelo is right - I was hasty with my implantable class III statement - it is implantable or class III

the paragraph was probably created from the reason Marcelo stated, however, the way it has been written allows for some flexibility...I would expect these to be extremely rare though

 

[MDRexpert]

Hi Everyone,
I have a questions related to COA. We are a contract manufacturer and our customer is asking for a COA for a raw material supplier. Can someone point me in the direction of what regulation specifies if we can or shouldn't? Can we send out the COA we have for our raw material supplier to the legal manufacturer?

Thanks!

 

[pkost]

you may struggle to get responses in this thread as your question isn't relevent to the original topic - maybe a moderator can split it off for you

Why are you concerned about handing out a CoA? there isn't a specific regulation about issuing CoAs that I'm aware of, but the MDD/MDR is clear that the legal manufacturer has a responsibility to make sure their product is within specification, they may decide that this includes a review of the CoA - I would expect it to be covered in any supply/technical agreement you have in place - if you signed the agreement that requires you to provide a CoA then there is your requirement

If you are concerned about disclosing your raw material supplier then I would consider that most manufacturers would also expect to know this so that they can control their product to ensure it is within specification.