Responsibilities of Importers / Distributors - MDR

[MDRResearcher]

Would you be so kind and describe how do you perform or plan to perform responsibilities of importers / distributors requested by MDR:
- making sure that the devices bear the CE marking
- labelling is in accordance with the Regulation
- have assigned a UDI where applicable
- verify that devices are registered in EUDAMED
- inform manufacturers and their authorized representatives in the event of complaints
- keep a register of complaints, non-conforming devices, recalls and withdrawals
- escalate non-compliance to authorities if they suspect that a device has been falsified or that there is a serious risk to health.
- cooperate with authorities and make available all the documentation and information they have at their disposal

Please correct me if I missed some of the responsibilities.

Please share how to implement vigilance (to what degree) for MD?

Thank you.

 

[MDRResearcher]

BUMP

Can someone please share practice advice how to implement vigilance for MD importer (Article 13)?

 

[shimonv]

You will need to develop internal procedures or policies to address each of the points you mentioned.
Also, some training would be useful..
It would be good if one of your supplier (MD manufacturer) can provide you with an example of vigilance procedure to work with.

 

[twanmul]

I'd also expect contracts with your suppliers to be updated/amended to reflect the updated responsibilities. This makes it clear that everyone is aware of what they should do and need to provide in order for you to execute your responsibilities fully.

 

[Disadolly]

I am receiving more and more requests from new potential distributors for the device technical files (which does have CE mark), which makes me uncomfortable as I do not wish to share proprietary information with a distributor. I have looked at MDR Article 13 for importers and 14 for distributors and point no 2 has some requirements but certainly not that we have to share our TF. Which documents from your technical file do you share routinely? And what do you send them when they request your e.g. risk management reports, clinical evaluation and biocompatibility reports?

 

[nozzle]

I am receiving more and more requests from new potential distributors for the device technical files (which does have CE mark), which makes me uncomfortable as I do not wish to share proprietary information with a distributor. I have looked at MDR Article 13 for importers and 14 for distributors and point no 2 has some requirements but certainly not that we have to share our TF. Which documents from your technical file do you share routinely? And what do you send them when they request your e.g. risk management reports, clinical evaluation and biocompatibility reports?

We also received a number of requests like this from distributors. We are only sharing the documents defined in article 14 and politely explain we are not required to send any further documentation.

 

[Mikilk]

It is important to understand the new roles of the EU reps (Article 11 of the MDR) Importers (Article 13) and Distributors (Article 14)
See also this Factsheet

 

[Vetty007]

We only share a few informations e.g. Vigilanz SOPs, Packaging and product Specifications, Performance reports, batch release reports and if needed e.g. the summary of the CER and also Biocompatibility, which we doesn't rate as that critical for our products (But until now biocompatibility is as expected and thus nothing new to people familiar with such kind of products).