Local (country) registration of medical devices - Who does it in best case?

[SANE]

Dear All,

I do not have a lot experience in the registration of products yet (IVD) and would be interested in your opinion.

Apart from the future registration in EUDAMED some national registration as in Spain, Italy or Turkey in Europe will remain but also registration outside of Europe might be required.
If there is a choice, is it better if distributors register a product or is it better if the manufacturer or its Authorized Representatives registers in the market where a product shall be sold by a distributor? I assume that it would be better if the manufacter or Auth REP registers locally, in particular of Non exclusive agreements with distributors so that manufacturers have a bit more the control in respect to the registration status.

Possibly I am too careful and your perspective would help me to sort this out.

 

[Jen Kirley]

Good day SANE,

I would still refer to REGULATION (EU) 2017/745 as the guide for responsibilities of distributors. Article 14 describes general obligations of distributors. Article 16 describes cases in which obligations of manufacturers apply to importers, distributors or other persons.

 

[EmiliaBedelia]

Dear All,

I do not have a lot experience in the registration of products yet (IVD) and would be interested in your opinion.

Apart from the future registration in EUDAMED some national registration as in Spain, Italy or Turkey in Europe will remain but also registration outside of Europe might be required.
If there is a choice, is it better if distributors register a product or is it better if the manufacturer or its Authorized Representatives registers in the market where a product shall be sold by a distributor? I assume that it would be better if the manufacter or Auth REP registers locally, in particular of Non exclusive agreements with distributors so that manufacturers have a bit more the control in respect to the registration status.

Possibly I am too careful and your perspective would help me to sort this out.

In some instances, you will not have a choice. There are certain countries where a foreign company is not permitted to register, they need an "in country" entity to do the registration. On the other hand, I have heard recently that France, for example, is not permitting registration by 3rd parties- they are only accepting registrations performed by the manufacturer. The registration requirements and expectations of the "in country" registrant will vary widely as well.

So, this will end up being a case by case basis. When it comes to AR vs. distributor, I think it would be 1) a question of capability - is the distributor equipped to do what you need them to do? and 2) business/exclusivity concerns - do you want the ability to sell to multiple distributors? Will your distributor allow you to do your registration with another AR or will they only work with you if they register the device (or vice versa)? Are there other concerns about having your registrations owned by a distributor? This is not really a regulatory concern so as long as you have the appropriate agreements in place, and a qualified person is performing the registration activities on your behalf, it would be up to you.